Blood conservation using antifibrinolytics in cardiac surgery
| ISRCTN | ISRCTN15166455 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15166455 |
| Secondary identifying numbers | MCT-52683 |
- 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
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 |
|---|---|
| phebert@ohri.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2002 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
K1H 8L6
Canada
Sponsor information
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Not defined
Not defined
725 Parkdale Avenue
Ottawa, Ontario
K1Y 4E9
Canada
| Phone | +1 613 761 4395 |
|---|---|
| phebert@ohri.ca | |
| Website | http://www.ohri.ca/home.asp |
"ROR" |
https://ror.org/03c62dg59 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52683)
No information available
Ontario Ministry of Health (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
