Status:
COMPLETED
Hetastarch and Bleeding Complications After Off-Pump Coronary Bypass Surgery
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Kaiser Foundation Research Institute
Conditions:
Postoperative Hemorrhage
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
There has been continuing debate about whether use of hetastarch for volume replacement in coronary artery bypass surgery \[CABG\] increases the risk of postoperative bleeding. A recent meta-analysis ...
Detailed Description
Recruitment 1. Eligibility screening: a. All adult Kaiser Permanente members admitted to Summit Hospital (Oakland, CA) for coronary bypass graft surgery which is planned to be conducted off-pump....
Eligibility Criteria
Inclusion
- Scheduled coronary bypass graft surgery that is planned to be conducted on adults off-pump (i.e., without use of cardio-pulmonary bypass).
Exclusion
- Scheduled coronary bypass graft surgery that is planned to be conducted on adults on-pump (i.e., with use of cardio-pulmonary bypass).
- A history of cardiac surgery
- A history of primary bleeding disorders
- End-stage renal disease
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00307138
Start Date
September 1 2004
End Date
August 1 2005
Last Update
May 22 2006
Active Locations (1)
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1
Summit Medical Center
Oakland, California, United States, 94611