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Table 1 Bleeding Academic Research Consortium (BARC) definitions

From: Platelet inhibition during ticagrelor monotherapy versus ticagrelor plus aspirin in patients with coronary artery disease (TEMPLATE study): study protocol for a randomised controlled trial

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

  1. *If a CABG-related bleed is not adjudicated as at least a type 3 severity event, it will be classified as not a bleeding event. If a bleeding event occurs with a clear temporal relationship to CABG (i.e. within a 48-h time frame) but does not meet type 4 severity criteria, it will be classified as not a bleeding event