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Blood conservation using antifibrinolytics in cardiac surgery
ISRCTN ISRCTN15166455
DOI 10.1186/ISRCTN15166455
ClinicalTrials.gov identifier
EudraCT number
Public title Blood conservation using antifibrinolytics in cardiac surgery
Scientific title Blood conservation using Antifibrinolytics: a Randomised Trial in a cardiac surgery population
Acronym BART
Serial number at source MCT-52683
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.
Lay summary
Ethics approval Research Ethics Board of The Ottawa Hospital approved on the 6th September 2002.
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Massive post-operative bleeding in high risk cardiac patients
Participants - 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
Participants - 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
Anticipated start date 01/04/2002
Anticipated end date 31/12/2008
Status of trial Completed
Patient information material
Target number of participants 2970
Interventions 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.
Primary outcome measure(s) Massive post-operative bleeding.
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)
Sources of funding 1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52683)
2. Ontario Ministry of Health (Canada)
Trial website http://www.ohri.ca
Publications 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18480196
Contact name Dr  Paul C.  Hebert
  Address The Ottawa Hospital - General Campus
Department of Medicine
501 Smyth Road
Room 1812-H
Box 201
  City/town Ottawa, Ontario
  Zip/Postcode K1H 8L6
  Country Canada
  Tel +1 613 737 8197
  Fax +1 613 739 6266
  Email phebert@ohri.ca
Sponsor Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
  Address 725 Parkdale Avenue
  City/town Ottawa, Ontario
  Zip/Postcode K1Y 4E9
  Country Canada
  Tel +1 613 761 4395
  Fax +1 613 761 4920
  Email phebert@ohri.ca
  Sponsor website: http://www.ohri.ca/home.asp
Date applied 01/09/2005
Last edited 27/01/2010
Date ISRCTN assigned 01/09/2005
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