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28 August 2008
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| [ Print-friendly version ] |
| Blood conservation using Antifibrinolytics: a Randomized Trial in a cardiac surgery population - the BART study |
| ISRCTN | ISRCTN15166455 |
| ClinicalTrials.gov identifier | |
| Public title | Blood conservation using Antifibrinolytics: a Randomized Trial in a cardiac surgery population - the BART study |
| Scientific title | |
| Acronym | BART |
| Serial number at source | MCT-52683 |
| Study hypothesis | We hypothesize 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 hypothesize 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 hypothesize that aprotinin will decrease life-threatening postoperative complications (death, myocardial infarction, and cerebrovascular accidents) in the 30 days following surgery. |
| Ethics approval | Ethics approval received from the Research Ethics Board of The Ottawa Hospital 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 | Ongoing |
| 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 postoperative 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 | 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 |
| phebert@ohri.ca | |
| Sponsor | Ottawa Health Research Institute (Canada) |
| Address | 725 Parkdale Avenue |
| City/town | Ottawa, Ontario |
| Zip/Postcode | K1Y 4E9 |
| Country | Canada |
| Tel | +1 613 761 4395 |
| Fax | +1 613 761 4920 |
| phebert@ohri.ca | |
| Date applied | 01/09/2005 |
| Last edited | 27/05/2008 |
| Date ISRCTN assigned | 01/09/2005 |
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