Background
Aims and objectives
Methods
Study design and setting
Study population
Patient approach and study visits
Study visit 1
Randomisation
Trial interventions
Study visit 2
Class | Definition |
---|---|
Type 0 | No bleeding. |
Type 1 | Bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalisation, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. |
Type 2 | Any overt, actionable sign of haemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: requiring nonsurgical, medical intervention by a healthcare professional, leading to hospitalisation or increased level of care, prompting evaluation. |
Type 3a | Overt bleeding plus haemoglobin drop of 3 to < 5 g/dL, corrected for transfusion (provided haemoglobin drop is related to bleed) OR any transfusion with overt bleeding. |
Type 3b | Overt bleeding plus haemoglobin drop < 5 g/dL, corrected for transfusion (provided haemoglobin drop is related to bleed) OR cardiac tamponade. Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/haemorrhoid) OR bleeding requiring intravenous vasoactive agents. |
Type 3c | Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal) Subcategories confirmed by autopsy or imaging or lumbar puncture OR intraocular bleed compromising vision. |
Type 4 | Coronary artery bypass graft (CABG)-related bleeding OR perioperative intracranial bleeding within 48 h OR reoperation after closure of sternotomy for the purpose of controlling bleeding OR transfusion of ≥ 5 U whole blood or packed red blood cells within a 48 h period (cell saver product are not included) OR chest tube output ≥ 2 L within a 24-h period.* |
Type 5a | Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious. |
Type 5b | Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation |