Contact information
Type
Scientific
Primary contact
Dr Paul C. Hebert
ORCID ID
Contact details
The Ottawa Hospital - General Campus
Department of Medicine
501 Smyth Road
Room 1812-H
Box 201
Ottawa
Ontario
K1H 8L6
Canada
+1 613 737 8197
phebert@ohri.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-52683
Study information
Scientific title
Blood conservation using Antifibrinolytics: a Randomised Trial in a cardiac surgery population
Acronym
BART
Study hypothesis
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
Research Ethics Board of The Ottawa Hospital approved on the 6th September 2002.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Aprotinin
Primary outcome measure
Massive post-operative bleeding.
Secondary outcome measures
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)
Overall trial start date
01/04/2002
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2970
Participant 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
Recruitment start date
01/04/2002
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Canada
Trial participating centre
The Ottawa Hospital - General Campus
Ottawa, Ontario
K1H 8L6
Canada
Sponsor information
Organisation
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Sponsor details
725 Parkdale Avenue
Ottawa
Ontario
K1Y 4E9
Canada
+1 613 761 4395
phebert@ohri.ca
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52683)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ontario Ministry of Health (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18480196
Publication citations
-
Results
Fergusson DA, Hébert PC, Mazer CD, Fremes S, MacAdams C, Murkin JM, Teoh K, Duke PC, Arellano R, Blajchman MA, Bussières JS, Côté D, Karski J, Martineau R, Robblee JA, Rodger M, Wells G, Clinch J, Pretorius R, , A comparison of aprotinin and lysine analogues in high-risk cardiac surgery., N. Engl. J. Med., 2008, 358, 22, 2319-2331, doi: 10.1056/NEJMoa0802395.