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

NCT00216957 | Completed Phase 3

• 1 other identifier: QE-RS/1998-220
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (3)

• Length of hospitalization

• Blood product utilization

• Post operative atrial fibrillation

Secondary Outcomes (2)

• Myocardial infarction

• Mortality

Interventions

Coronary bypass surgery without cardiopulmonary bypass PROCEDURE

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient suitable for CABG surgery

You may not qualify if:

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

Sponsors & Collaborators

• Maritime Heart Centre: lead

Study Sites (1)

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Coronary Artery Bypass; Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Extracorporeal Circulation

Study Officials

• Jean-Francois Legare, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 1998
• Study Completion: June 1, 2004
• Last Updated: September 22, 2005

Record last verified: 2005-09

Locations

CA (1)