Condition category
Signs and Symptoms
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
27/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ohri.ca

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 measures

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

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

http://www.ohri.ca/home.asp

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18480196

Publication citations

  1. 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.

Additional files

Editorial Notes