Description

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

 


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