Blood conservation using antifibrinolytics in cardiac surgery

ISRCTN	ISRCTN15166455
DOI	https://doi.org/10.1186/ISRCTN15166455
Protocol serial number	MCT-52683
Sponsor	Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52683), Ontario Ministry of Health (Canada)

Submission date: 01/09/2005
Registration date: 01/09/2005
Last edited: 27/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul C. Hebert
Scientific

The Ottawa Hospital - General Campus
Department of Medicine
501 Smyth Road
Room 1812-H
Box 201
Ottawa, Ontario
K1H 8L6
Canada

Phone	+1 613 737 8197
Email	phebert@ohri.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Blood conservation using Antifibrinolytics: a Randomised Trial in a cardiac surgery population
Study acronym	BART
Study objectives	We hypothesise that aprotinin will result in a 3% absolute risk reduction in massive postoperative bleeding in the initial 24 hours following surgery (6% to 3%) as compared to epsilon-aminocaproic acid or tranexamic acid in patients undergoing high-risk cardiac surgical procedures. We also hypothesise that aprotinin will result in a 10% absolute risk reduction in allogeneic exposure to any blood product (50% to 40%) as compared to the other two antifibrinolytic agents in the 30 days following surgery. Finally, we hypothesise that aprotinin will decrease life-threatening postoperative complications (death, myocardial infarction, and cerebrovascular accidents) in the 30 days following surgery.
Ethics approval(s)	Research Ethics Board of The Ottawa Hospital approved on the 6th September 2002.
Health condition(s) or problem(s) studied	Massive post-operative bleeding in high risk cardiac patients
Intervention	Group 1: Aprotinin (2 million unit bolus and 2 million units in pump prime and 2 million units via infusion over 4 hours) Group 2: Tranexamic acid (100 mg/kg post induction) or epsilon-amnicaproic acid (10 g loading dose followed by 2 g/hour while on cardiopulmonary bypass) For further information, please contact Dr. Paul Hebert at the address listed below or Dr. Dean Fergusson at the e-mail address: dafergusson@ohri.ca Please note that the trial end recruitment date has been extended from 30th September 2005 to 31st December 2008.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Aprotinin
Primary outcome measure(s)	Massive post-operative bleeding.
Key secondary outcome measure(s)	1. 30 day all cause mortality 2. Myocardial infarction 3. Cerebrovascular accidents (focal neurologic deficit lasting more than 24 hours 4. Dialysis dependent renal failure by a double of creatinine 5. Need for prolonged invasive mechanical ventilatory support (greater than 48 hours) 6. A prolonged low output state (need for vasopressors, balloon pump or ventricular assist device for more than 48 hours)
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2970
Key inclusion criteria	1. Aged 18 years and older, either sex 2. Re-operation for coronary artery bypass graft (CABG) 3. Re-operation for aortic valve replacement with a CABG 4. Mitral valve replacement (initial or re-operation) 5. Aortic and mitral valve replacement with a CABG 6. Multiple valve replacement (initial or reoperation) 7. Other procedures including Bental procedure and re-operation for adult congenital heart procedures
Key exclusion criteria	1. Less than 18 years of age 2. Refuse consent (refusal from patient or physician) 3. Have a terminal illness with a life expectancy less than 3 months. 4. Have been previously enrolled in this study 5. Are currently enrolled in another perioperative interventional study 6. Are unable to receive blood products 7. Have had previous exposure to aprotinin 8. Have a thrombocytopenia defined as a platelet count less than 100,000/mm^3 9. Have a coagulopathy defined as an International Normalised Ratio (INR) equalling 1.5 prior to surgery or the immediate preoperative use of tPA or streptokinase
Date of first enrolment	01/04/2002
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Canada

Study participating centre

The Ottawa Hospital - General Campus

Ottawa, Ontario
K1H 8L6
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/05/2008		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes