A toolkit for the collection of thrombosis-related data elements in COVID-19 clinical studies

Cui

Chen

Liu

Wang

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Tritschler

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Subcommittee on Predictive and Diagnostic Variables in Thrombotic Disease

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Subcommittee on Control of Anticoagulation

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Author notes

The full-text version of this article contains a data supplement.

2020

Table 1.

VTE data elements

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of acute VTE	Date VTE diagnosed: MM/DD/YYYY	Date VTE diagnosed: MM/DD/YYYY	Date VTE diagnosed: MM/DD/YYYY
Anticoagulant therapy at time of event	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Type and location of VTE	Type and location of VTE (select one) ☐ DVT ☐ Lower extremity DVT ☐ Upper extremity/neck DVT ☐ Non-limb DVT ☐ Superficial vein thrombosis ☐ PE Fatal PE ☐ Yes ☐ No ☐ Unknown	Type and location of VTE (select all that apply): ☐ DVT ☐ Lower extremity DVT Select location(s): ☐ Right ☐ Left Select the most proximal involved veins: ☐ Proximal veins (IVC, iliac, femoral, popliteal veins) ☐ Calf veins (anterior tibial, posterior tibial, peroneal, soleal, gastrocnemius) ☐ Upper extremity/neck DVT Select location(s): ☐ Right ☐ Left ☐ Non-limb venous thrombosis ☐ Splanchnic vein (portal, splenic, or mesenteric) ☐ Cerebral venous sinus ☐ Renal vein ☐ Gonadal veins ☐ Other (specify): ___________________ ☐ Superficial vein thrombosis ☐ PE (choose one): Fatal PE ☐ Yes ☐ No ☐ Unknown Select location(s): ☐ Unknown location (ie, presumed PE due to inability to obtain imaging and based on clinical presentation and ancillary tests [eg, echocardiogram]) ☐ Subsegmental pulmonary arteries only ☐ Segmental or larger pulmonary artery	Type and location of VTE (select all that apply): ☐ DVT ☐ Lower extremity DVT Select location(s): ☐ Right ☐ Left Select the most proximal involved vein: ☐ IVC ☐ Iliac vein ☐ Femoral vein ☐ Popliteal vein ☐ Calf veins (anterior tibial, posterior tibial, peroneal, soleal, gastrocnemius) Associated with central venous catheter? ☐ Yes ☐ No ☐ Unknown ☐ Upper extremity/neck DVT Select location(s): ☐ Right ☐ Left Select most proximal involved vein: ☐ Distal to axillary vein (radial, ulnar) ☐ Axillary ☐ Subclavian ☐ Internal jugular ☐ Brachiocephalic ☐ Innominate ☐ SVC Associated with central venous catheter? ☐ Yes ☐ No ☐ Unknown ☐ Non-limb venous thrombosis ☐ Splanchnic vein (portal, splenic, or mesenteric) ☐ Cerebral venous sinus ☐ Renal vein ☐ Gonadal veins ☐ Other (specify): ___________________ ☐ Superficial vein thrombosis Select location(s): ☐ Lower extremity ☐ Upper extremity Associated with peripheral or central venous catheter? ☐ Yes ☐ No ☐ Unknown ☐ PE (choose one): Fatal PE ☐ Yes ☐ No ☐ Unknown Select location(s): ☐ Unknown location (ie, presumed PE due to inability to obtain imaging and based on clinical presentation and ancillary tests [eg, echocardiogram]) ☐ Subsegmental pulmonary arteries only ☐ Segmental or larger pulmonary artery
Symptoms of VTE		☐ Asymptomatic, detected on systematic VTE screening test ☐ Incidental finding on a test performed for another indication ☐ Symptoms triggered testing ☐ Unknown	☐ Asymptomatic, detected on systematic VTE screening test ☐ Incidental finding on a test performed for another indication ☐ Symptoms triggered testing ☐ Unknown
Diagnosis of VTE	☐ Objectively confirmed using diagnostic imaging (eg, CTPA, V/Q scan, ultrasound, MRI) ☐ Clinical/empirical diagnosis only → indicate reason(s) objective confirmation not done: ☐ Unable to obtain imaging due to clinical status of patient (eg, hemodynamically unstable) ☐ Unable to obtain imaging due to resource limitations (eg, timely imaging not available) ☐ Unable to obtain imaging due to need for patient isolation or risk of infectious exposure ☐ Other (specify): ____________ ☐ Unknown	☐ Objectively confirmed using diagnostic imaging (eg, CTPA, V/Q scan, ultrasound, MRI) ☐ Clinical/empirical diagnosis only → indicate reason(s) objective confirmation not done: ☐ Unable to obtain imaging due to clinical status of patient (eg, hemodynamically unstable) ☐ Unable to obtain imaging due to resource limitations (eg, timely imaging not available) ☐ Unable to obtain imaging due to need for patient isolation or risk of infectious exposure ☐ Other (specify): ____________ ☐ Unknown	☐ Objectively confirmed using diagnostic imaging (select all that apply) PE diagnostic findings → ☐ High-probability V/Q or positive SPECT V/Q ☐ Intraluminal filling defect on CTPA ☐ Other (specify): __________________ DVT diagnostic findings → ☐ Lack of compressibility of a deep vein on compression ultrasound ☐ Intraluminal filling defect on CT venography ☐ Intraluminal filling defect on MRI/MRV ☐ Other (specify): ___________________ ☐ Clinical/empirical diagnosis only → indicate reason(s) objective confirmation not done: ☐ Unable to obtain imaging due to clinical status of patient (eg, hemodynamically unstable) ☐ Unable to obtain imaging due to resource limitations (eg, timely imaging not available) ☐ Unable to obtain imaging due to need for patient isolation ☐ Unknown
Antithrombotic treatment of VTE			Antithrombotic therapy form
Additional interventions			Additional interventions for VTE (select all that apply) ☐ Thrombolysis–systemic ☐ Thrombolysis–catheter directed ☐ Mechanical thrombectomy ☐ IVC filter insertion ☐ Other (specify): _________________________ ☐ Unknown

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of acute VTE	Date VTE diagnosed: MM/DD/YYYY	Date VTE diagnosed: MM/DD/YYYY	Date VTE diagnosed: MM/DD/YYYY
Anticoagulant therapy at time of event	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Type and location of VTE	Type and location of VTE (select one) ☐ DVT ☐ Lower extremity DVT ☐ Upper extremity/neck DVT ☐ Non-limb DVT ☐ Superficial vein thrombosis ☐ PE Fatal PE ☐ Yes ☐ No ☐ Unknown	Type and location of VTE (select all that apply): ☐ DVT ☐ Lower extremity DVT Select location(s): ☐ Right ☐ Left Select the most proximal involved veins: ☐ Proximal veins (IVC, iliac, femoral, popliteal veins) ☐ Calf veins (anterior tibial, posterior tibial, peroneal, soleal, gastrocnemius) ☐ Upper extremity/neck DVT Select location(s): ☐ Right ☐ Left ☐ Non-limb venous thrombosis ☐ Splanchnic vein (portal, splenic, or mesenteric) ☐ Cerebral venous sinus ☐ Renal vein ☐ Gonadal veins ☐ Other (specify): ___________________ ☐ Superficial vein thrombosis ☐ PE (choose one): Fatal PE ☐ Yes ☐ No ☐ Unknown Select location(s): ☐ Unknown location (ie, presumed PE due to inability to obtain imaging and based on clinical presentation and ancillary tests [eg, echocardiogram]) ☐ Subsegmental pulmonary arteries only ☐ Segmental or larger pulmonary artery	Type and location of VTE (select all that apply): ☐ DVT ☐ Lower extremity DVT Select location(s): ☐ Right ☐ Left Select the most proximal involved vein: ☐ IVC ☐ Iliac vein ☐ Femoral vein ☐ Popliteal vein ☐ Calf veins (anterior tibial, posterior tibial, peroneal, soleal, gastrocnemius) Associated with central venous catheter? ☐ Yes ☐ No ☐ Unknown ☐ Upper extremity/neck DVT Select location(s): ☐ Right ☐ Left Select most proximal involved vein: ☐ Distal to axillary vein (radial, ulnar) ☐ Axillary ☐ Subclavian ☐ Internal jugular ☐ Brachiocephalic ☐ Innominate ☐ SVC Associated with central venous catheter? ☐ Yes ☐ No ☐ Unknown ☐ Non-limb venous thrombosis ☐ Splanchnic vein (portal, splenic, or mesenteric) ☐ Cerebral venous sinus ☐ Renal vein ☐ Gonadal veins ☐ Other (specify): ___________________ ☐ Superficial vein thrombosis Select location(s): ☐ Lower extremity ☐ Upper extremity Associated with peripheral or central venous catheter? ☐ Yes ☐ No ☐ Unknown ☐ PE (choose one): Fatal PE ☐ Yes ☐ No ☐ Unknown Select location(s): ☐ Unknown location (ie, presumed PE due to inability to obtain imaging and based on clinical presentation and ancillary tests [eg, echocardiogram]) ☐ Subsegmental pulmonary arteries only ☐ Segmental or larger pulmonary artery
Symptoms of VTE		☐ Asymptomatic, detected on systematic VTE screening test ☐ Incidental finding on a test performed for another indication ☐ Symptoms triggered testing ☐ Unknown	☐ Asymptomatic, detected on systematic VTE screening test ☐ Incidental finding on a test performed for another indication ☐ Symptoms triggered testing ☐ Unknown
Diagnosis of VTE	☐ Objectively confirmed using diagnostic imaging (eg, CTPA, V/Q scan, ultrasound, MRI) ☐ Clinical/empirical diagnosis only → indicate reason(s) objective confirmation not done: ☐ Unable to obtain imaging due to clinical status of patient (eg, hemodynamically unstable) ☐ Unable to obtain imaging due to resource limitations (eg, timely imaging not available) ☐ Unable to obtain imaging due to need for patient isolation or risk of infectious exposure ☐ Other (specify): ____________ ☐ Unknown	☐ Objectively confirmed using diagnostic imaging (eg, CTPA, V/Q scan, ultrasound, MRI) ☐ Clinical/empirical diagnosis only → indicate reason(s) objective confirmation not done: ☐ Unable to obtain imaging due to clinical status of patient (eg, hemodynamically unstable) ☐ Unable to obtain imaging due to resource limitations (eg, timely imaging not available) ☐ Unable to obtain imaging due to need for patient isolation or risk of infectious exposure ☐ Other (specify): ____________ ☐ Unknown	☐ Objectively confirmed using diagnostic imaging (select all that apply) PE diagnostic findings → ☐ High-probability V/Q or positive SPECT V/Q ☐ Intraluminal filling defect on CTPA ☐ Other (specify): __________________ DVT diagnostic findings → ☐ Lack of compressibility of a deep vein on compression ultrasound ☐ Intraluminal filling defect on CT venography ☐ Intraluminal filling defect on MRI/MRV ☐ Other (specify): ___________________ ☐ Clinical/empirical diagnosis only → indicate reason(s) objective confirmation not done: ☐ Unable to obtain imaging due to clinical status of patient (eg, hemodynamically unstable) ☐ Unable to obtain imaging due to resource limitations (eg, timely imaging not available) ☐ Unable to obtain imaging due to need for patient isolation ☐ Unknown
Antithrombotic treatment of VTE			Antithrombotic therapy form
Additional interventions			Additional interventions for VTE (select all that apply) ☐ Thrombolysis–systemic ☐ Thrombolysis–catheter directed ☐ Mechanical thrombectomy ☐ IVC filter insertion ☐ Other (specify): _________________________ ☐ Unknown

CT, computed tomography; CTPA, computed tomography pulmonary angiogram; DVT, deep vein thrombosis; IVC, inferior vena cava; MRI, magnetic resonance imaging; MRV, magnetic resonance venography; PE, pulmonary embolism; SPECT, single-photon emission computed tomography; SVC, superior vena cava; V/Q, ventilation/perfusion.

Table 2.

Myocardial infarction (MI) data elements

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of acute MI	Date acute MI diagnosed: DD/MM/YYYY	Date acute MI diagnosed: DD/MM/YYYY	Date acute MI diagnosed: DD/MM/YYYY
Antithrombotic therapy at time of MI	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Type of acute MI			Select one: ☐ Type 1: spontaneous ☐ Type 2: ischemic imbalance ☐ Type 3: death, no biomarkers ☐ Type 4a: percutaneous coronary intervention related ☐ Type 4b: stent thrombosis ☐ Type 5: coronary artery bypass grafting related ☐ Unknown
Cardiovascular risk factors	Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity	Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity	Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity
Symptoms of acute MI	Presence of symptoms of myocardial ischemia: ☐ No ☐ Yes ☐ Unknown	Presence of symptoms of myocardial ischemia: ☐ No ☐ Yes ☐ Unknown	Presence of symptoms of myocardial ischemia: ☐ No ☐ Yes ☐ Unknown
Acute ischemic ECG changes	Presence of new or presumed new ischemic ECG changes ☐ No ☐ Yes ☐ Unknown	Presence of new or presumed new ischemic ECG changes ☐ No ☐ Yes ☐ Ischemic changes on ECG ☐ Left bundle branch block ☐ Unknown	Presence of new or presumed new ischemic ECG changes ☐ No ☐ Yes ☐ Ischemic changes on ECG ☐ Left bundle branch block ☐ Unknown
New Q waves on ECG	Presence of new Q waves: ☐ No ☐ Yes ☐ Unknown	Presence of new Q waves: ☐ No ☐ Yes ☐ Unknown	Presence of new Q waves: ☐ No ☐ Yes ☐ Unknown
Change in noninvasive imaging	Change in noninvasive imaging ☐ No ☐ Yes ☐ Unknown	Change in noninvasive imaging ☐ No ☐ Yes ☐ New loss of viable myocardium ☐ New regional wall motion abnormality ☐ Unknown	Change in noninvasive imaging ☐ No ☐ Yes ☐ New loss of viable myocardium ☐ New regional wall motion abnormality ☐ Unknown
Cardiac biomarker	Cardiac biomarker >99% upper reference limit ☐ No ☐ Yes ☐ Unknown	Cardiac biomarker >99% upper reference limit ☐ No ☐ Yes, specify biomarker: ______________ ☐ Unknown	Cardiac biomarker >99% upper reference limit ☐ No ☐ Yes, specify biomarker: ___________________ ☐ Unknown
Reperfusion treatment	Did the patient undergo reperfusion treatment of this MI: ☐ No (medical management) ☐ Yes ☐ Unknown	Did the patient undergo reperfusion treatment of this MI: ☐ No (medical management) ☐ Yes (select all that apply): ☐ Percutaneous coronary intervention ☐ Coronary artery bypass grafting ☐ Systemic thrombolytic therapy ☐ Other (specify): ____________ ☐ Unknown	Did the patient undergo reperfusion treatment of this MI: ☐ No (medical management) ☐ Yes (select all that apply): ☐ Percutaneous coronary intervention ☐ Coronary artery bypass grafting ☐ Systemic thrombolytic therapy ☐ Other (specify): ____________ ☐ Unknown
Antithrombotic treatment of MI			Antithrombotic therapy form

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of acute MI	Date acute MI diagnosed: DD/MM/YYYY	Date acute MI diagnosed: DD/MM/YYYY	Date acute MI diagnosed: DD/MM/YYYY
Antithrombotic therapy at time of MI	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Type of acute MI			Select one: ☐ Type 1: spontaneous ☐ Type 2: ischemic imbalance ☐ Type 3: death, no biomarkers ☐ Type 4a: percutaneous coronary intervention related ☐ Type 4b: stent thrombosis ☐ Type 5: coronary artery bypass grafting related ☐ Unknown
Cardiovascular risk factors	Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity	Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity	Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity
Symptoms of acute MI	Presence of symptoms of myocardial ischemia: ☐ No ☐ Yes ☐ Unknown	Presence of symptoms of myocardial ischemia: ☐ No ☐ Yes ☐ Unknown	Presence of symptoms of myocardial ischemia: ☐ No ☐ Yes ☐ Unknown
Acute ischemic ECG changes	Presence of new or presumed new ischemic ECG changes ☐ No ☐ Yes ☐ Unknown	Presence of new or presumed new ischemic ECG changes ☐ No ☐ Yes ☐ Ischemic changes on ECG ☐ Left bundle branch block ☐ Unknown	Presence of new or presumed new ischemic ECG changes ☐ No ☐ Yes ☐ Ischemic changes on ECG ☐ Left bundle branch block ☐ Unknown
New Q waves on ECG	Presence of new Q waves: ☐ No ☐ Yes ☐ Unknown	Presence of new Q waves: ☐ No ☐ Yes ☐ Unknown	Presence of new Q waves: ☐ No ☐ Yes ☐ Unknown
Change in noninvasive imaging	Change in noninvasive imaging ☐ No ☐ Yes ☐ Unknown	Change in noninvasive imaging ☐ No ☐ Yes ☐ New loss of viable myocardium ☐ New regional wall motion abnormality ☐ Unknown	Change in noninvasive imaging ☐ No ☐ Yes ☐ New loss of viable myocardium ☐ New regional wall motion abnormality ☐ Unknown
Cardiac biomarker	Cardiac biomarker >99% upper reference limit ☐ No ☐ Yes ☐ Unknown	Cardiac biomarker >99% upper reference limit ☐ No ☐ Yes, specify biomarker: ______________ ☐ Unknown	Cardiac biomarker >99% upper reference limit ☐ No ☐ Yes, specify biomarker: ___________________ ☐ Unknown
Reperfusion treatment	Did the patient undergo reperfusion treatment of this MI: ☐ No (medical management) ☐ Yes ☐ Unknown	Did the patient undergo reperfusion treatment of this MI: ☐ No (medical management) ☐ Yes (select all that apply): ☐ Percutaneous coronary intervention ☐ Coronary artery bypass grafting ☐ Systemic thrombolytic therapy ☐ Other (specify): ____________ ☐ Unknown	Did the patient undergo reperfusion treatment of this MI: ☐ No (medical management) ☐ Yes (select all that apply): ☐ Percutaneous coronary intervention ☐ Coronary artery bypass grafting ☐ Systemic thrombolytic therapy ☐ Other (specify): ____________ ☐ Unknown
Antithrombotic treatment of MI			Antithrombotic therapy form

ECG, electrocardiogram.

Table 3.

Stroke/Transient ischemic attack (TIA) data elements

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of acute stroke/TIA	Date acute stroke/TIA diagnosed: DD/MM/YYYY	Date acute stroke/TIA diagnosed: DD/MM/YYYY	Date acute stroke/TIA diagnosed: DD/MM/YYYY
Antithrombotic therapy at time of event	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Stroke/TIA subtype	Select one: ☐ TIA ☐ Stroke (select one type below) ☐ Ischemic stroke ☐ Hemorrhagic stroke ☐ Unknown	Select one: ☐ TIA ☐ Stroke (select one type below) ☐ Ischemic stroke Etiology of ischeimc stroke (select one): ☐ Cardioembolic ☐ Small vessel disease ☐ Large vessel disease ☐ Other identified cause ☐ Undetermined etiology Was ischemic stroke complicated by hemorrhagic transformation? ☐ No ☐ Yes ☐ Unknown ☐ Hemorrhagic stroke ☐ Unknown	Select one: ☐ TIA ☐ Stroke (select one type below) ☐ Ischemic stroke Etiology of ischemic stroke (select one): ☐ Cardioembolic (select all that apply) ☐ Atrial fibrillation/flutter ☐ Acute MI (<2 wk) ☐ Intracardiac thrombus ☐ Rheumatic mitral stenosis ☐ Sick sinus syndrome ☐ Dilated cardiomyopathy ☐ Prosthetic heart valve ☐ Akinesis of ventricular wall ☐ Ischemic cardiomyopathy (EF <28%) ☐ Paradoxical embolism ☐ Other ☐ Small vessel disease ☐ Large vessel disease ☐ Other identified cause ☐ Undetermined etiology Was ischemic stroke complicated by hemorrhagic transformation? ☐ No ☐ Yes ☐ Unknown ☐ Hemorrhagic stroke (select all that apply) ☐ Lobar ☐ Basal ganglia ☐ Brainstem ☐ Intraventricular involvement ☐ Cerebellum ☐ Other (specify): ____________ ☐ Unknown ☐ Unknown
Cardiovascular risk factors			Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity
Presenting symptoms		Select one: ☐ No ☐ Yes (select one) ☐ Focal symptom ☐ Non–focal symptom ☐ Other neurologic symptom ☐ Unknown	Select one: ☐ No ☐ Yes (select one) ☐ Focal symptom ☐ Non–focal symptom ☐ Other neurologic symptom ☐ Unknown
Duration of symptoms			Select one: ☐ 24 h or longer ☐ Less than 24 h ☐ Unknown
Neuroimaging	Was neuroimaging done for this event? ☐ No ☐ Yes ☐ Unknown	Was neuroimaging done for this event? ☐ No ☐ Yes (indicate type of image, select all that apply) ☐ Single brain CT scan ☐ Multiple brain CT scans separated in time ☐ MRI ☐ Diffusion-weighted MRI ☐ Unknown	Was neuroimaging done for this event? ☐ No ☐ Yes (indicate type of image, select all that apply) ☐ Single brain CT scan (select one) ☐ Positive ☐ Negative ☐ Result not available ☐ Multiple brain CT scans separated in time (select one) ☐ Positive ☐ Negative ☐ Result not available ☐ MRI (select one) ☐ Positive ☐ Negative ☐ Result not available ☐ Diffusion-weighted MRI (select one) ☐ Positive ☐ Negative ☐ Result not available ☐ Unknown
Reperfusion treatment	Did the patient undergo reperfusion treatment of this stroke: ☐ No (medical management) ☐ Yes ☐ Unknown	Did the patient undergo reperfusion treatment of this stroke: ☐ No (medical management) ☐ Yes (select all that apply): ☐ Mechanical thrombectomy ☐ Systemic thrombolytic therapy ☐ Other (specify): ____________ ☐ Unknown	Did the patient undergo reperfusion treatment of this stroke: ☐ No (medical management) ☐ Yes (select all that apply): ☐ Mechanical thrombectomy ☐ Systemic thrombolytic therapy ☐ Other (specify): ____________ ☐ Unknown
Antithrombotic treatment of stroke/TIA			Antithrombotic therapy form

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of acute stroke/TIA	Date acute stroke/TIA diagnosed: DD/MM/YYYY	Date acute stroke/TIA diagnosed: DD/MM/YYYY	Date acute stroke/TIA diagnosed: DD/MM/YYYY
Antithrombotic therapy at time of event	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Stroke/TIA subtype	Select one: ☐ TIA ☐ Stroke (select one type below) ☐ Ischemic stroke ☐ Hemorrhagic stroke ☐ Unknown	Select one: ☐ TIA ☐ Stroke (select one type below) ☐ Ischemic stroke Etiology of ischeimc stroke (select one): ☐ Cardioembolic ☐ Small vessel disease ☐ Large vessel disease ☐ Other identified cause ☐ Undetermined etiology Was ischemic stroke complicated by hemorrhagic transformation? ☐ No ☐ Yes ☐ Unknown ☐ Hemorrhagic stroke ☐ Unknown	Select one: ☐ TIA ☐ Stroke (select one type below) ☐ Ischemic stroke Etiology of ischemic stroke (select one): ☐ Cardioembolic (select all that apply) ☐ Atrial fibrillation/flutter ☐ Acute MI (<2 wk) ☐ Intracardiac thrombus ☐ Rheumatic mitral stenosis ☐ Sick sinus syndrome ☐ Dilated cardiomyopathy ☐ Prosthetic heart valve ☐ Akinesis of ventricular wall ☐ Ischemic cardiomyopathy (EF <28%) ☐ Paradoxical embolism ☐ Other ☐ Small vessel disease ☐ Large vessel disease ☐ Other identified cause ☐ Undetermined etiology Was ischemic stroke complicated by hemorrhagic transformation? ☐ No ☐ Yes ☐ Unknown ☐ Hemorrhagic stroke (select all that apply) ☐ Lobar ☐ Basal ganglia ☐ Brainstem ☐ Intraventricular involvement ☐ Cerebellum ☐ Other (specify): ____________ ☐ Unknown ☐ Unknown
Cardiovascular risk factors			Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity
Presenting symptoms		Select one: ☐ No ☐ Yes (select one) ☐ Focal symptom ☐ Non–focal symptom ☐ Other neurologic symptom ☐ Unknown	Select one: ☐ No ☐ Yes (select one) ☐ Focal symptom ☐ Non–focal symptom ☐ Other neurologic symptom ☐ Unknown
Duration of symptoms			Select one: ☐ 24 h or longer ☐ Less than 24 h ☐ Unknown
Neuroimaging	Was neuroimaging done for this event? ☐ No ☐ Yes ☐ Unknown	Was neuroimaging done for this event? ☐ No ☐ Yes (indicate type of image, select all that apply) ☐ Single brain CT scan ☐ Multiple brain CT scans separated in time ☐ MRI ☐ Diffusion-weighted MRI ☐ Unknown	Was neuroimaging done for this event? ☐ No ☐ Yes (indicate type of image, select all that apply) ☐ Single brain CT scan (select one) ☐ Positive ☐ Negative ☐ Result not available ☐ Multiple brain CT scans separated in time (select one) ☐ Positive ☐ Negative ☐ Result not available ☐ MRI (select one) ☐ Positive ☐ Negative ☐ Result not available ☐ Diffusion-weighted MRI (select one) ☐ Positive ☐ Negative ☐ Result not available ☐ Unknown
Reperfusion treatment	Did the patient undergo reperfusion treatment of this stroke: ☐ No (medical management) ☐ Yes ☐ Unknown	Did the patient undergo reperfusion treatment of this stroke: ☐ No (medical management) ☐ Yes (select all that apply): ☐ Mechanical thrombectomy ☐ Systemic thrombolytic therapy ☐ Other (specify): ____________ ☐ Unknown	Did the patient undergo reperfusion treatment of this stroke: ☐ No (medical management) ☐ Yes (select all that apply): ☐ Mechanical thrombectomy ☐ Systemic thrombolytic therapy ☐ Other (specify): ____________ ☐ Unknown
Antithrombotic treatment of stroke/TIA			Antithrombotic therapy form

EF, ejection fraction; TIA, transient ischemic attack.

Table 4.

Peripheral arterial and other arterial thrombosis data elements

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of acute arterial ischemic event	Date acute arterial ischemic event diagnosed: MM/DD/YYYY	Date acute arterial ischemic event diagnosed: MM/DD/YYYY	Date acute arterial ischemic event diagnosed: MM/DD/YYYY
Antithrombotic therapy at time of event	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Type of event	Indicate type of arterial thrombotic event (select one): ☐ Peripheral arterial thromboembolism ☐ Abdominal arterial thromboembolism ☐ Microvascular thrombosis ☐ Other (specify): ________________________	Indicate type of arterial thrombotic event (select one): ☐ Peripheral arterial thromboembolism ☐ Abdominal arterial thromboembolism ☐ Microvascular thrombosis ☐ Other (specify): ________________________	Indicate type of arterial thrombotic event (select one): ☐ Peripheral arterial thromboembolism (select one) ☐ Atherosclerotic plaque ☐ Arterial embolism ☐ Other known cause (specify): _____________ ☐ Unknown ☐ Abdominal arterial thromboembolism (select one) ☐ Atherosclerotic plaque ☐ Arterial embolism ☐ Other known cause (specify): _____________ ☐ Unknown ☐ Microvascular thrombosis (select one) ☐ Diagnosed on biopsy ☐ Biopsy not done ☐ Unknown ☐ Other (specify): ________________________
Cardiovascular risk factors			Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity
Reperfusion treatment (vascular intervention)		Did the patient undergo reperfusion treatment of this arterial thrombotic event: ☐ No ☐ Yes (select all that apply): ☐ Angioplasty ☐ Stent ☐ Bypass ☐ Systemic thrombolytic therapy ☐ Catheter-directed thrombolytic therapy ☐ Embolectomy ☐ Other (specify): ____________ ☐ Unknown	Did the patient undergo reperfusion treatment of this arterial thrombotic event: ☐ No ☐ Yes (select all that apply): ☐ Angioplasty ☐ Stent ☐ Bypass ☐ Systemic thrombolytic therapy ☐ Catheter-directed thrombolytic therapy ☐ Embolectomy ☐ Other (specify): ____________ ☐ Unknown
Limb amputation		Did the patient undergo limb amputation? ☐ No ☐ Yes ☐ Unknown	Did the patient undergo limb amputation? ☐ No ☐ Yes ☐ Unknown
Antithrombotic treatment of thrombotic event			Antithrombotic therapy form

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of acute arterial ischemic event	Date acute arterial ischemic event diagnosed: MM/DD/YYYY	Date acute arterial ischemic event diagnosed: MM/DD/YYYY	Date acute arterial ischemic event diagnosed: MM/DD/YYYY
Antithrombotic therapy at time of event	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Type of event	Indicate type of arterial thrombotic event (select one): ☐ Peripheral arterial thromboembolism ☐ Abdominal arterial thromboembolism ☐ Microvascular thrombosis ☐ Other (specify): ________________________	Indicate type of arterial thrombotic event (select one): ☐ Peripheral arterial thromboembolism ☐ Abdominal arterial thromboembolism ☐ Microvascular thrombosis ☐ Other (specify): ________________________	Indicate type of arterial thrombotic event (select one): ☐ Peripheral arterial thromboembolism (select one) ☐ Atherosclerotic plaque ☐ Arterial embolism ☐ Other known cause (specify): _____________ ☐ Unknown ☐ Abdominal arterial thromboembolism (select one) ☐ Atherosclerotic plaque ☐ Arterial embolism ☐ Other known cause (specify): _____________ ☐ Unknown ☐ Microvascular thrombosis (select one) ☐ Diagnosed on biopsy ☐ Biopsy not done ☐ Unknown ☐ Other (specify): ________________________
Cardiovascular risk factors			Select all that apply: ☐ Known cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebrovascular disease) ☐ Hypertension ☐ Diabetes mellitus ☐ Current smoker ☐ Former smoker ☐ Hypercholesterolemia ☐ Obesity
Reperfusion treatment (vascular intervention)		Did the patient undergo reperfusion treatment of this arterial thrombotic event: ☐ No ☐ Yes (select all that apply): ☐ Angioplasty ☐ Stent ☐ Bypass ☐ Systemic thrombolytic therapy ☐ Catheter-directed thrombolytic therapy ☐ Embolectomy ☐ Other (specify): ____________ ☐ Unknown	Did the patient undergo reperfusion treatment of this arterial thrombotic event: ☐ No ☐ Yes (select all that apply): ☐ Angioplasty ☐ Stent ☐ Bypass ☐ Systemic thrombolytic therapy ☐ Catheter-directed thrombolytic therapy ☐ Embolectomy ☐ Other (specify): ____________ ☐ Unknown
Limb amputation		Did the patient undergo limb amputation? ☐ No ☐ Yes ☐ Unknown	Did the patient undergo limb amputation? ☐ No ☐ Yes ☐ Unknown
Antithrombotic treatment of thrombotic event			Antithrombotic therapy form

Table 5.

Bleeding data elements

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of bleeding event	Date acute bleeding event diagnosed: MM/DD/YYYY	Date acute bleeding event diagnosed: MM/DD/YYYY	Date acute bleeding event diagnosed: MM/DD/YYYY
Antithrombotic therapy at time of bleeding event	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Type of bleeding event–ISTH definitions	Indicate type of bleeding event (select one): ☐ Major bleeding ☐ Clinically relevant non-major bleeding ☐ Other bleeding (specify): ________________________ ☐ Unknown	Indicate type of bleeding event (select one): ☐ Major bleeding (choose all that apply) ☐ Fatal bleeding ☐ Symptomatic bleeding in a critical area or organ ☐ Overt bleeding causing a fall in hemoglobin level of 20 g/L (2 g/dL, 1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red blood cells ☐ Clinically relevant non-major bleeding (choose all that apply) ☐ Requiring medical intervention by a health care professional ☐ Leading to hospitalization or increased level of care ☐ Prompting an evaluation ☐ Other bleeding (specify): ________________________ ☐ Unknown	Indicate type of bleeding event (select one): ☐ Major bleeding (choose all that apply) ☐ Fatal bleeding ☐ Symptomatic bleeding in a critical area or organ ☐ Overt bleeding causing a fall in hemoglobin level of 20 g/L (2 g/dL, 1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red blood cells ☐ Clinically relevant non-major bleeding (choose all that apply) ☐ Requiring medical intervention by a health care professional ☐ Leading to hospitalization or increased level of care ☐ Prompting an evaluation ☐ Other bleeding (specify): ________________________ ☐ Unknown
Blood products given for bleeding			Select all that apply: ☐ Red blood cell transfusion ☐ Whole blood transfusion ☐ Plasma transfusion ☐ Platelet transfusion ☐ Cryoprecipitate ☐ Fibrinogen concentrate ☐ Prothrombin complex concentrate (4-factor) ☐ Prothrombin complex concentrate (3-factor) ☐ Activated prothrombin complex concentrate ☐ Recombinant factor VIIa ☐ Other (specify): __________________________
Hemostatic treatments given for bleeding event			Indicate hemostatic treatments given (select all that apply): ☐ Tranexamic acid ☐ Aminocaproic acid ☐ Desmopressin (DDAVP)
Specific anticoagulant reversal agents			Select all that apply: ☐ Idarucizumab ☐ Andexanet alfa
Surgeries or invasive procedures to treat acute bleeding			Did the patient undergo surgery or invasive procedure to treat bleeding? ☐ No ☐ Yes (select all that apply): ☐ Surgery ☐ Endoscopic procedure ☐ Angioembolization ☐ Other (specify): _______________________ ☐ Unknown

Variable	Level 1 (basic)	Level 2 (intermediate)	Level 3 (comprehensive)
Date of bleeding event	Date acute bleeding event diagnosed: MM/DD/YYYY	Date acute bleeding event diagnosed: MM/DD/YYYY	Date acute bleeding event diagnosed: MM/DD/YYYY
Antithrombotic therapy at time of bleeding event	Antithrombotic therapy form	Antithrombotic therapy form	Antithrombotic therapy form
Type of bleeding event–ISTH definitions	Indicate type of bleeding event (select one): ☐ Major bleeding ☐ Clinically relevant non-major bleeding ☐ Other bleeding (specify): ________________________ ☐ Unknown	Indicate type of bleeding event (select one): ☐ Major bleeding (choose all that apply) ☐ Fatal bleeding ☐ Symptomatic bleeding in a critical area or organ ☐ Overt bleeding causing a fall in hemoglobin level of 20 g/L (2 g/dL, 1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red blood cells ☐ Clinically relevant non-major bleeding (choose all that apply) ☐ Requiring medical intervention by a health care professional ☐ Leading to hospitalization or increased level of care ☐ Prompting an evaluation ☐ Other bleeding (specify): ________________________ ☐ Unknown	Indicate type of bleeding event (select one): ☐ Major bleeding (choose all that apply) ☐ Fatal bleeding ☐ Symptomatic bleeding in a critical area or organ ☐ Overt bleeding causing a fall in hemoglobin level of 20 g/L (2 g/dL, 1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red blood cells ☐ Clinically relevant non-major bleeding (choose all that apply) ☐ Requiring medical intervention by a health care professional ☐ Leading to hospitalization or increased level of care ☐ Prompting an evaluation ☐ Other bleeding (specify): ________________________ ☐ Unknown
Blood products given for bleeding			Select all that apply: ☐ Red blood cell transfusion ☐ Whole blood transfusion ☐ Plasma transfusion ☐ Platelet transfusion ☐ Cryoprecipitate ☐ Fibrinogen concentrate ☐ Prothrombin complex concentrate (4-factor) ☐ Prothrombin complex concentrate (3-factor) ☐ Activated prothrombin complex concentrate ☐ Recombinant factor VIIa ☐ Other (specify): __________________________
Hemostatic treatments given for bleeding event			Indicate hemostatic treatments given (select all that apply): ☐ Tranexamic acid ☐ Aminocaproic acid ☐ Desmopressin (DDAVP)
Specific anticoagulant reversal agents			Select all that apply: ☐ Idarucizumab ☐ Andexanet alfa
Surgeries or invasive procedures to treat acute bleeding			Did the patient undergo surgery or invasive procedure to treat bleeding? ☐ No ☐ Yes (select all that apply): ☐ Surgery ☐ Endoscopic procedure ☐ Angioembolization ☐ Other (specify): _______________________ ☐ Unknown

DDAVP, 1-deamino-8-D-arginine vasopressin.

Table 6.

Laboratory testing data elements

Variable	Level 1 (basic)		Level 2 (intermediate)		Level 3 (comprehensive)
At study enrollment
Hemoglobin	Hemoglobin	____________	Hemoglobin	____________	Hemoglobin	____________
Hemoglobin	Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L	Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L	Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L
Platelet count	Platelet count	__________________	Platelet count	_________________	Platelet count	__________________
	Platelet count units	☐ per μL ☐ × 10⁹/L	Platelet count units	☐ per μL ☐ × 10⁹/L	Platelet count units	☐ per μL ☐ × 10⁹/L
PT	PT	__________ s	PT	__________ s	PT	__________ s
PT	PT reference range	______ to ______ s	PT reference range	______ to ______ s	PT reference range	______ to ______ s
aPTT	aPTT	___________ s	aPTT	___________ s	aPTT	___________ s
aPTT	aPTT reference range	______ to ______ s	aPTT reference range	______ to ______ s	aPTT reference range	______ to ______ s
Fibrinogen activity	Fibrinogen activity	______________	Fibrinogen activity	______________	Fibrinogen activity	______________
Fibrinogen activity	Fibrinogen activity units	☐ g/L ☐ mg/dL	Fibrinogen activity units	☐ g/L ☐ mg/dL	Fibrinogen activity units	☐ g/L ☐ mg/dL
D-dimer	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay
	D-dimer upper limit of assay	Indicate upper limit _______	D-dimer upper limit of assay	Indicate upper limit _______	D-dimer upper limit of assay	Indicate upper limit _______
	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ________	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ______	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ________
	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimer HS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): __	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimer HS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): __	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimerHS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): __
At the time of thrombotic event
Hemoglobin					Hemoglobin	____________
Hemoglobin					Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L
Platelet count			Platelet count	__________________	Platelet count	__________________
			Platelet count units	☐ per μL ☐ × 10⁹/L	Platelet count units	☐ per μL ☐ × 10⁹/L
PT			PT	__________ s	PT	__________ s
PT			PT reference range	______ to ______ s	PT reference range	______ to ______ s
aPTT			aPTT	___________ s	aPTT	___________ s
aPTT			aPTT reference range	______ to ______ s	aPTT reference range	______ to ______ s
Fibrinogen			Fibrinogen activity level	______________	Fibrinogen activity level	______________
Fibrinogen			Fibrinogen activity units	☐ g/L ☐ mg/dL	Fibrinogen activity units	☐ g/L ☐ mg/dL
Anti-Xa activity (for patients receiving heparin, LMWH)					☐ Heparin ☐ LMWH	_______________ U/mL
Antithrombin					Antithrombin	☐ ___________ % ☐______________ IU/dL
					Antithrombin reference range	_______ to _______ IU/dL
D-dimer	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay
	D-dimer upper limit of assay	Indicate upper limit _______	D-dimer upper limit of assay	Indicate upper limit _______	D-dimer upper limit of assay	Indicate upper limit _______
	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ____	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ____	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ____
	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimer HS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): _____	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimer HS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): _____	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimerHS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): ______
Serum creatinine					Serum creatinine	______________
Serum creatinine					Creatinine units	☐ µmol/L ☐ mg/dL
At the time of bleeding event
Hemoglobin	Hemoglobin	____________	Hemoglobin	____________	Hemoglobin	____________
Hemoglobin	Hemoglobin units	☐ g/L ☐ mg/dL	Hemoglobin units	☐ g/L ☐ mg/dL	Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L
Platelet count	Platelet count	____________	Platelet count	____________	Platelet count	____________
	Platelet count units	☐ per μL ☐ × 10⁹/L	Platelet count units	☐ per μL ☐× 10⁹/L	Platelet count units	☐ per μL ☐ × 10⁹/L
PT					PT	level __________ s
PT					PT reference range	______ to ______ s
aPTT					aPTT	___________ s
aPTT					aPTT reference range	______ to ______ s
INR					INR	________________
Fibrinogen activity					Fibrinogen activity	______________
Fibrinogen activity					Fibrinogen activity units	☐ g/L ☐ mg/dL

Variable	Level 1 (basic)		Level 2 (intermediate)		Level 3 (comprehensive)
At study enrollment
Hemoglobin	Hemoglobin	____________	Hemoglobin	____________	Hemoglobin	____________
Hemoglobin	Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L	Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L	Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L
Platelet count	Platelet count	__________________	Platelet count	_________________	Platelet count	__________________
	Platelet count units	☐ per μL ☐ × 10⁹/L	Platelet count units	☐ per μL ☐ × 10⁹/L	Platelet count units	☐ per μL ☐ × 10⁹/L
PT	PT	__________ s	PT	__________ s	PT	__________ s
PT	PT reference range	______ to ______ s	PT reference range	______ to ______ s	PT reference range	______ to ______ s
aPTT	aPTT	___________ s	aPTT	___________ s	aPTT	___________ s
aPTT	aPTT reference range	______ to ______ s	aPTT reference range	______ to ______ s	aPTT reference range	______ to ______ s
Fibrinogen activity	Fibrinogen activity	______________	Fibrinogen activity	______________	Fibrinogen activity	______________
Fibrinogen activity	Fibrinogen activity units	☐ g/L ☐ mg/dL	Fibrinogen activity units	☐ g/L ☐ mg/dL	Fibrinogen activity units	☐ g/L ☐ mg/dL
D-dimer	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay
	D-dimer upper limit of assay	Indicate upper limit _______	D-dimer upper limit of assay	Indicate upper limit _______	D-dimer upper limit of assay	Indicate upper limit _______
	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ________	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ______	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ________
	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimer HS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): __	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimer HS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): __	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimerHS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): __
At the time of thrombotic event
Hemoglobin					Hemoglobin	____________
Hemoglobin					Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L
Platelet count			Platelet count	__________________	Platelet count	__________________
			Platelet count units	☐ per μL ☐ × 10⁹/L	Platelet count units	☐ per μL ☐ × 10⁹/L
PT			PT	__________ s	PT	__________ s
PT			PT reference range	______ to ______ s	PT reference range	______ to ______ s
aPTT			aPTT	___________ s	aPTT	___________ s
aPTT			aPTT reference range	______ to ______ s	aPTT reference range	______ to ______ s
Fibrinogen			Fibrinogen activity level	______________	Fibrinogen activity level	______________
Fibrinogen			Fibrinogen activity units	☐ g/L ☐ mg/dL	Fibrinogen activity units	☐ g/L ☐ mg/dL
Anti-Xa activity (for patients receiving heparin, LMWH)					☐ Heparin ☐ LMWH	_______________ U/mL
Antithrombin					Antithrombin	☐ ___________ % ☐______________ IU/dL
					Antithrombin reference range	_______ to _______ IU/dL
D-dimer	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay	D-dimer level (indicate absolute level, or level above upper limit of assay)	☐ Absolute level _________ ☐ Level above upper limit of assay
	D-dimer upper limit of assay	Indicate upper limit _______	D-dimer upper limit of assay	Indicate upper limit _______	D-dimer upper limit of assay	Indicate upper limit _______
	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ____	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ____	D-dimer units (choose one)	☐ mg/L ☐ μg/mL ☐ ng/mL ☐ Other (specify): ____
	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimer HS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): _____	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimer HS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): _____	D-dimer commercial assay (choose one)	☐ IL HemosIL D-dimer ☐ IL HemosIL D-dimerHS ☐ IL HemosILD-dimer HS500 ☐ Radiometer AQT90 Flex ☐ Siemens Innovance ☐ Siemens Acute Care ☐ Stago/Roche Liatest D-dimer ☐ Stago Liatest D-dimer Plus ☐ Roche Cardiac Reader DD test ☐ Roche Tina-quant 2nd gen ☐ bioMérieux Vidas ☐ Diagon Dia-D-Dimer ☐ Beckman Coulter D-Dimer ☐ Diagnostica STA Liatest ☐ Other (specify): ______
Serum creatinine					Serum creatinine	______________
Serum creatinine					Creatinine units	☐ µmol/L ☐ mg/dL
At the time of bleeding event
Hemoglobin	Hemoglobin	____________	Hemoglobin	____________	Hemoglobin	____________
Hemoglobin	Hemoglobin units	☐ g/L ☐ mg/dL	Hemoglobin units	☐ g/L ☐ mg/dL	Hemoglobin units	☐ g/L ☐ mg/dL ☐ mmol/L
Platelet count	Platelet count	____________	Platelet count	____________	Platelet count	____________
	Platelet count units	☐ per μL ☐ × 10⁹/L	Platelet count units	☐ per μL ☐× 10⁹/L	Platelet count units	☐ per μL ☐ × 10⁹/L
PT					PT	level __________ s
PT					PT reference range	______ to ______ s
aPTT					aPTT	___________ s
aPTT					aPTT reference range	______ to ______ s
INR					INR	________________
Fibrinogen activity					Fibrinogen activity	______________
Fibrinogen activity					Fibrinogen activity units	☐ g/L ☐ mg/dL

aPTT, activated partial thromboplastin time; INR, international normalized ratio; LMWH, low-molecular-weight heparin; PT, prothrombin time.

Table 7.

Antithrombotic therapy form (refer to Antithrombotic Therapy Dictionary)

Date antithrombotic therapy form completed

(MM/DD/YYYY): ________________

Indicate patient’s most recent documented or reported weight at the time of thrombotic event:

__________ kg, OR __________ lb, OR ☐ unknown

Height

__________ cm, OR __________ inches, OR ☐ unknown

Section 1: Anticoagulant treatment:

☐ No ☐ Yes (indicate the type, dose, and frequency below)

☐ Low-molecular-weight heparin

Drug

Dose

Frequency

☐ Enoxaparin

__________

☐ mg
☐ mg/kg
☐ units
☐ units/kg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Dalteparin

__________

☐ units
☐ units/kg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Tinzaparin

__________

☐ units
☐ units/kg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Nadroparin

__________

☐ units
☐ units/kg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Certoparin

__________

☐ units
☐ units/kg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Bemiparin

__________

☐ units
☐ units/kg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Other (specify):________

__________

☐ mg
☐ mg/kg
☐ units
☐ units/kg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Unfractionated heparin (indicate method of administration and dose, frequency):

Route of administration

Dose

Frequency

☐ Intravenous infusion

__________

Units/kg/h

Continuous infusion

☐ Subcutaneous

__________

☐ units
☐ units/kg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Fondaparinux (indicate dose and frequency):

Dose

Frequency

________ mg

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Other (specify):________

☐ Direct oral anticoagulants (indicate drug, dose, frequency):

Drug

Dose and frequency

☐ Apixaban

☐ 2.5 mg twice daily
☐ 5 mg twice daily
☐ 10 mg twice daily
☐ Other (specify):________

☐ Rivaroxaban

☐ 2.5 mg twice daily
☐ 10 mg once daily
☐ 15 mg once daily
☐ 15 mg twice daily
☐ 20 mg once daily
☐ Other (specify):________

☐ Edoxaban

☐ 30 mg once daily
☐ 60 mg once daily
☐ Other (specify):________

☐ Dabigatran

☐ 75 mg twice daily
☐ 110 mg twice daily
☐ 150 mg twice daily
☐ 220 mg once daily
☐ Other (specify):________

☐ Vitamin K antagonist (indicate drug and target INR):

Drug

Target INR

☐ Warfarin
☐ Phenprocoumon
☐ Acenocoumarol
☐ Fluindione
☐ Other (specify): _______________
☐ Unknown

☐ INR 1.5 to 2.5
☐ INR 2 to 3
☐ INR 2.5 to 3.5
☐ Other (specify): _____________________
☐ Unknown

☐ Unknown anticoagulant

☐ Other anticoagulant not listed above (specify below):

Drug

Dose

Route

Frequency

Argatroban

__________

☐ μg/kg/min
☐ Other (specify): ______

Intravenous

☐ Continuous infusion
☐ Other (specify):________

Bivalirudin

__________

☐ mg/kg/h
☐ Other (specify): _______

Intravenous

☐ Continuous infusion
☐ Other (specify):________

Other (specify): _______________

__________

☐ mg
☐ mg/kg
☐ mg/kg/h
☐ units
☐ units/kg
☐ μg/kg/min

☐ Oral
☐ Subcutaneous
☐ Intravenous

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Continuous infusion
☐ Other (specify):________

Section 2: Antiplatelet therapy:

☐ No ☐ Yes (indicate the type, dose, and frequency below)

☐ Aspirin (acetylsalicylic acid)

☐ Low dose (≤100 mg daily)
☐ 325 mg once daily
☐ Other (specify): _____________

☐ Clopidogrel

☐ 75 mg once daily
☐ 150 mg once daily

☐ Ticagrelor

☐ 60 mg twice daily
☐ 90 mg twice daily

☐ Prasugrel

☐ 5 mg once daily
☐ 10 mg once daily

☐ Acetylsalicylic acid and dipyridamole ER

☐ Aspirin 25 mg/dipyridamole ER 200 mg twice daily
☐ Aspirin 25 mg/dipyridamole ER 200 mg once daily

☐ Cangrelor

☐ 30 μg/kg bolus then 4 μg/kg/min (for percutaneous intervention)
☐ 0.75 μg/kg/min (for bridging therapy before cardiac surgery)

☐ Other antiplatelet therapy, including nonsteroidal anti-inflammatory drugs (specify below):

Dose

Route

Frequency

________

☐ mg
☐ units
☐ Other (specify): ________

☐ Oral
☐ Subcutaneous
☐ Intravenous

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Continuous infusion
☐ Other (specify):________

________

☐ mg
☐ units
☐ Other (specify): ________

☐ Oral
☐ Subcutaneous
☐ Intravenous

☐ Every 24 h
☐ Every 12 h
☐ Every 8 h
☐ Continuous infusion
☐ Other (specify):________

Section 3: Mechanical thromboprophylaxis:

☐ No ☐ Yes (indicate the type below)

☐ Intermittent pneumatic compression
☐ Graduated compression stockings
☐ Antiembolism stockings
☐ Other (specify):

Date antithrombotic therapy form completed		(MM/DD/YYYY): ________________
Indicate patient’s most recent documented or reported weight at the time of thrombotic event:		__________ kg, OR __________ lb, OR ☐ unknown
Height		__________ cm, OR __________ inches, OR ☐ unknown
Section 1: Anticoagulant treatment:		☐ No ☐ Yes (indicate the type, dose, and frequency below)
☐ Low-molecular-weight heparin	Drug	Dose		Frequency
	☐ Enoxaparin	__________	☐ mg ☐ mg/kg ☐ units ☐ units/kg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
	☐ Dalteparin	__________	☐ units ☐ units/kg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
	☐ Tinzaparin	__________	☐ units ☐ units/kg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
	☐ Nadroparin	__________	☐ units ☐ units/kg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
	☐ Certoparin	__________	☐ units ☐ units/kg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
	☐ Bemiparin	__________	☐ units ☐ units/kg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
	☐ Other (specify):________	__________	☐ mg ☐ mg/kg ☐ units ☐ units/kg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
☐ Unfractionated heparin (indicate method of administration and dose, frequency):	Route of administration	Dose		Frequency
	☐ Intravenous infusion	__________	Units/kg/h	Continuous infusion
	☐ Subcutaneous	__________	☐ units ☐ units/kg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
☐ Fondaparinux (indicate dose and frequency):	Dose	Frequency
	________ mg	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Other (specify):________
☐ Direct oral anticoagulants (indicate drug, dose, frequency):	Drug	Dose and frequency
	☐ Apixaban	☐ 2.5 mg twice daily ☐ 5 mg twice daily ☐ 10 mg twice daily ☐ Other (specify):________
	☐ Rivaroxaban	☐ 2.5 mg twice daily ☐ 10 mg once daily ☐ 15 mg once daily ☐ 15 mg twice daily ☐ 20 mg once daily ☐ Other (specify):________
	☐ Edoxaban	☐ 30 mg once daily ☐ 60 mg once daily ☐ Other (specify):________
	☐ Dabigatran	☐ 75 mg twice daily ☐ 110 mg twice daily ☐ 150 mg twice daily ☐ 220 mg once daily ☐ Other (specify):________
☐ Vitamin K antagonist (indicate drug and target INR):	Drug	Target INR
	☐ Warfarin ☐ Phenprocoumon ☐ Acenocoumarol ☐ Fluindione ☐ Other (specify): _______________ ☐ Unknown	☐ INR 1.5 to 2.5 ☐ INR 2 to 3 ☐ INR 2.5 to 3.5 ☐ Other (specify): _____________________ ☐ Unknown
☐ Unknown anticoagulant
☐ Other anticoagulant not listed above (specify below):	Drug	Dose		Route	Frequency
	Argatroban	__________	☐ μg/kg/min ☐ Other (specify): ______	Intravenous	☐ Continuous infusion ☐ Other (specify):________
	Bivalirudin	__________	☐ mg/kg/h ☐ Other (specify): _______	Intravenous	☐ Continuous infusion ☐ Other (specify):________
	Other (specify): _______________	__________	☐ mg ☐ mg/kg ☐ mg/kg/h ☐ units ☐ units/kg ☐ μg/kg/min	☐ Oral ☐ Subcutaneous ☐ Intravenous	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Continuous infusion ☐ Other (specify):________
Section 2: Antiplatelet therapy:	☐ No ☐ Yes (indicate the type, dose, and frequency below)
☐ Aspirin (acetylsalicylic acid)	☐ Low dose (≤100 mg daily) ☐ 325 mg once daily ☐ Other (specify): _____________
☐ Clopidogrel	☐ 75 mg once daily ☐ 150 mg once daily
☐ Ticagrelor	☐ 60 mg twice daily ☐ 90 mg twice daily
☐ Prasugrel	☐ 5 mg once daily ☐ 10 mg once daily
☐ Acetylsalicylic acid and dipyridamole ER	☐ Aspirin 25 mg/dipyridamole ER 200 mg twice daily ☐ Aspirin 25 mg/dipyridamole ER 200 mg once daily
☐ Cangrelor	☐ 30 μg/kg bolus then 4 μg/kg/min (for percutaneous intervention) ☐ 0.75 μg/kg/min (for bridging therapy before cardiac surgery)
☐ Other antiplatelet therapy, including nonsteroidal anti-inflammatory drugs (specify below):	Dose		Route	Frequency
	________	☐ mg ☐ units ☐ Other (specify): ________	☐ Oral ☐ Subcutaneous ☐ Intravenous	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Continuous infusion ☐ Other (specify):________
	________	☐ mg ☐ units ☐ Other (specify): ________	☐ Oral ☐ Subcutaneous ☐ Intravenous	☐ Every 24 h ☐ Every 12 h ☐ Every 8 h ☐ Continuous infusion ☐ Other (specify):________
Section 3: Mechanical thromboprophylaxis:	☐ No ☐ Yes (indicate the type below)
☐ Intermittent pneumatic compression ☐ Graduated compression stockings ☐ Antiembolism stockings ☐ Other (specify):

ER, extended release; INR, international normalized ratio.

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