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

• Sponsor: Maritime Heart Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT00216957
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Duration (Months): 68
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease	Procedure: Coronary bypass surgery without cardiopulmonary bypass	Phase 3

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).

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass
• Study Start Date: Oct 1, 1998
• Study Completion Date: Jun 1, 2004

Outcome Measures

Primary Outcome Measures

1. Length of hospitalization []

2. Blood product utilization []

3. Post operative atrial fibrillation []

Secondary Outcome Measures

1. Myocardial infarction []

2. Mortality []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Any patient suitable for CABG surgery

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia	Canada	B3H 3A7

Sponsors and Collaborators

• Maritime Heart Centre

Investigators

• Principal Investigator: Jean-Francois Legare, MD, Dalhousie University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00216957
• Other Study ID Numbers: QE-RS/1998-220
• First Posted: Sep 22, 2005
• Last Update Posted: Sep 22, 2005
• Last Verified: Sep 1, 2005

• Additional relevant MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease

Study Results

No Results Posted as of Sep 22, 2005