Table 2 Definition of bleeding events
Major bleeding | Clinically overt bleeding that is associated with: |
A fall in haemoglobin of 2 g/dl or more, or | |
A transfusion of 2 or more units of packed red blood cells or whole blood, or | |
A critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or | |
A fatal outcome | |
Non-major clinically relevant bleeding | Non-major clinically relevant bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a clinician, (temporary) cessation of warfarin treatment, or associated with discomfort for the subject such as pain or impairment of activities of daily life. |
Examples of non-major clinically relevant bleeding are: | |
• Epistaxis if it lasts for more than 5 minutes, if it is repetitive (i.e., 2 or more episodes of true bleeding, i.e., not spots on a handkerchief, within 24 hours), or leads to an intervention (packing, electrocautery, etc.) and no admission to hospital. | |
• Gingival bleeding if it occurs spontaneously (i.e., unrelated to tooth brushing or eating), or if it lasts for more than 5 minutes | |
• Haematuria if it is macroscopic, and either spontaneous or lasts for more than 24 hours after instrumentation (e.g., catheter placement or surgery) of the urogenital tract | |
• Macroscopic gastrointestinal haemorrhage: at least 1 episode of melena or hematemesis, if clinically apparent | |
• Rectal blood loss, if more than a few spots | |
• Haemoptysis, if more than a few speckles in the sputum, or | |
• Intramuscular hematoma | |
• Subcutaneous hematoma if the size is larger than 25 cm2 or larger than 100 cm2 if provoked |