Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass

Last updated: September 19, 2005
Sponsor: Maritime Heart Centre
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Circulation Disorders

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT00216957
QE-RS/1998-220
  • All Genders

Study Summary

Coronary artery bypass grafting (CABG) is a well established treatment modality for patients with coronary artery disease. For 30 years now CABG operations have been performed with the help of the heart lung machine (Cardiopulmonary bypass). However, the heart lung machine is believed to be responsible for many of the side effects and complications seen in patients following CABG surgery. The organs most commonly affected are the brain, blood constituents, lungs and kidneys.

In the last few years, stabilising devices have been developed that allow CABG operations to be performed safely without the use of the heart lung machine. Our hypothesis was that CABG done without the heart lung machine may be better tolerated by patients resulting in lower morbidity, increased functional outcome and shorter hospital length of stay.

Enrolment into the trial was from 1998 to 2003 and included 300 patients. The last patient was enrolled in June of 2003. The initial results from the study suggest that excellent results can be obtained with both techniques and contrary to others no advantages could be demonstrated in in-hospital outcomes of patients performed without cardiopulmonary bypass (Legare et al. Circulation 2005).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any patient suitable for CABG surgery

Exclusion

Exclusion Criteria:

  • Emergency, concomitant procedure, low ejection fraction (<20%)

Study Design

Total Participants: 300
Study Start date:
October 01, 1998
Estimated Completion Date:
June 30, 2004

Study Description

We are now in follow-up to evaluate the medium term and long term outcomes of all 300 patients originally enrolled in above mentioned randomized clinical trial. The follow-up of patients is approved by the Capital Health Research Ethics Board (CDHA-RS/2004-295).

Connect with a study center

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia B3H 3A7
    Canada

    Site Not Available

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