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.