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Table 2 Definition of bleeding events

From: Trial Protocol: A randomised controlled trial of extended anticoagulation treatment versus routine anticoagulation treatment for the prevention of recurrent VTE and post thrombotic syndrome in patients being treated for a first episode of unprovoked VTE (The ExACT Study)

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