Status:
TERMINATED
Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
Lead Sponsor:
Duke University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized trial to see in patients undergoing coronary artery bypass grafting and endoscopically-harvested greater saphenous vein, if using FloSeal Matrix in the endoscopically...
Detailed Description
Purpose of Study: The primary objective of this study is to determine if using a hemostatic agent (FloSeal Matrix™) in the tunnel of the endoscopically harvested Greater Saphenous vein will decrease b...
Eligibility Criteria
Inclusion
- Sign a consent form that has been approved by the Institutional Review Board.
- Be at least 18 years of age.
- Scheduled to undergo coronary artery bypass grafting with EVH.
- Be able to return to Duke University Medical Center for post-operative visit.
Exclusion
- Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Reported allergy to FloSeal Matrix™
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00742313
Start Date
June 1 2009
End Date
September 1 2012
Last Update
March 5 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710