The Bleeding Academic Research Consortium (BARC) has listed criteria to report bleeding in cardiovascular clinical trials.
Bleeding |
Type |
none |
0 |
minor |
1 |
moderate |
2 |
severe |
3 |
severe, CABG-related |
4 |
fatal |
5 |
Features of moderate (Type 1) bleeding – all of the following:
(1) some degree of bleeding
(2) does not meet criteria for Types 2, 3, 4 or 5
(3) has one or more of the following:
(3a) bleeding that does not require an action
(3b) bleeding that does not cause the patient to seek treatment
(3c) bleeding that the patient handles without consulting a clinician
Features of moderate (Type 2) bleeding – all of the following:
(1) overt bleeding
(2) does not meet criteria for Types 3, 4 or 5
(3) has at least one of the following:
(3a) requires nonsurgical intervention by a healthcare professional
(3b) results in hospitalization
(3c) results in a medical assessment
Type |
Features |
3a |
overt bleeding with transfusion overt bleeding causing a fall in hemoglobin 3 to 4.99 g/dL |
3b |
overt bleeding causing a fall in hemoglobin >= 5 g/dL cardiac tamponade bleeding requiring surgical intervention (except dermal, nasal, hemorrhoid or dental) bleeding requiring intravenous vasoactive agents (pressors) |
3c |
intracranial hemorrhage (except microbleed, hemorrhagic transformation or intraspinal) intraocular bleeding the compromises vision |
Features of CABG-related severe bleeding – one or more of the following:
(1) perioperative intracranial bleeding (within 48 hours)
(2) reoperation after closure of sternotomy to control bleeding
(3) chest tube output during 24 hours >= 2 liters blood
(4) transfusion of >= 5 units of blood within a 48 hour period
Exceptions for CABG-related bleeding:
(1) must be severe (Type 3)
(2) must have a clear temporal relation to the CABG (within 48 hours)
Type |
Features |
5a |
probable, not confirmed by objective study |
5b |
definite, confirmed by objective study |
Specialty: Hematology Oncology, Clinical Laboratory, Pharmacology, clinical