Laboratory testing data elements
| Variable . | Level 1 (basic) . | Level 2 (intermediate) . | Level 3 (comprehensive) . | |||
|---|---|---|---|---|---|---|
| At study enrollment | ||||||
| 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 reference range | ______ to ______ s | PT reference range | ______ to ______ s | PT reference range | ______ to ______ s | |
| aPTT | aPTT | ___________ s | aPTT | ___________ s | aPTT | ___________ s |
| 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 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 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 reference range | ______ to ______ s | PT reference range | ______ to ______ s | |||
| aPTT | aPTT | ___________ s | aPTT | ___________ s | ||
| aPTT reference range | ______ to ______ s | aPTT reference range | ______ to ______ s | |||
| Fibrinogen | Fibrinogen activity level | ______________ | Fibrinogen activity level | ______________ | ||
| 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 | ______________ | ||||
| Creatinine units | ☐ µmol/L ☐ mg/dL | |||||
| At the time of bleeding event | ||||||
| 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 reference range | ______ to ______ s | |||||
| aPTT | aPTT | ___________ s | ||||
| aPTT reference range | ______ to ______ s | |||||
| INR | INR | ________________ | ||||
| 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 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 reference range | ______ to ______ s | PT reference range | ______ to ______ s | PT reference range | ______ to ______ s | |
| aPTT | aPTT | ___________ s | aPTT | ___________ s | aPTT | ___________ s |
| 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 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 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 reference range | ______ to ______ s | PT reference range | ______ to ______ s | |||
| aPTT | aPTT | ___________ s | aPTT | ___________ s | ||
| aPTT reference range | ______ to ______ s | aPTT reference range | ______ to ______ s | |||
| Fibrinogen | Fibrinogen activity level | ______________ | Fibrinogen activity level | ______________ | ||
| 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 | ______________ | ||||
| Creatinine units | ☐ µmol/L ☐ mg/dL | |||||
| At the time of bleeding event | ||||||
| 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 reference range | ______ to ______ s | |||||
| aPTT | aPTT | ___________ s | ||||
| aPTT reference range | ______ to ______ s | |||||
| INR | INR | ________________ | ||||
| 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.