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Clinical Trials/NCT00216957
NCT00216957
Completed
Phase 3

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

Maritime Heart Centre1 site in 1 country300 target enrollmentOctober 1998

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Ischemic Heart Disease
Sponsor
Maritime Heart Centre
Enrollment
300
Locations
1
Primary Endpoint
Length of hospitalization
Status
Completed
Last Updated
20 years ago

Overview

Brief 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).

Detailed 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).

Registry
clinicaltrials.gov
Start Date
October 1998
End Date
June 2004
Last Updated
20 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Maritime Heart Centre

Eligibility Criteria

Inclusion Criteria

  • Any patient suitable for CABG surgery

Exclusion Criteria

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

Outcomes

Primary Outcomes

Length of hospitalization

Blood product utilization

Post operative atrial fibrillation

Secondary Outcomes

  • Myocardial infarction
  • Mortality

Study Sites (1)

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