Table 2 Criteria for major, clinically relevant non-major and minor bleeding

Major bleeding

• Associated with a fall in hemoglobin of 2 g/dL or more

• Leading to a transfusion of two or more units of packed red blood cells or whole blood

• Occurring in a critical site: intracranial, intra-spinal, intra-ocular, pericardial, intra-articular, intramuscular with compartment syndrome, retro-peritoneal

• Contributing to death

Clinically relevant non-major bleeding

• Any bleeding compromising hemodynamics

• Any bleeding leading to hospitalization

• Subcutaneous hematoma larger than 25 cm², or 100 cm² if there was a traumatic cause

• Intramuscular hematoma documented by ultrasonography

• Epistaxis lasting > 5 minutes, repetitive (defined as two or more episodes of bleeding more extensive than spots on a handkerchief within 24 hours), or leading to an intervention (e.g.,,, packing or electrocoagulation)

• Gingival bleeding occurring spontaneously (not related to eating, flossing or tooth brushing) or lasting > 5 minutes

• Macroscopic spontaneous hematuria or hematuria that lasted > 24 hours after instrumentation (e.g., catheter placement or surgery) of the urogenital tract

• Macroscopic gastrointestinal hemorrhage, including at least one episode of melena or hematemesis, with positive results on a fecal occult-blood test

• Hemoptysis, if more than a few speckles in the sputum and not occurring within the context of pulmonary embolism

• Any other bleeding type considered to have clinical consequences for a patient such as medical intervention, the need for unscheduled contact (visit or telephone call) with a physician, or temporary cessation of a study drug or associated with pain or impairment of daily life activities

Minor bleeding

All other overt bleeding episodes not meeting the criteria for major or clinically relevant bleeding or post-partum bleeding.