Status:
COMPLETED
Cardiac Surgery: In Vivo Titration of Protamine
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
Organon
Conditions:
Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Safe use of cardiopulmonary bypass (CPB) requires massive doses of intravenous unfractionated heparin. At end-CPB, residual heparin is neutralized with intravenous injection of protamine sulfate. This...
Detailed Description
Protamine sulfate is administered to reverse the anticoagulant effects of heparin upon completion of cardiopulmonary bypass (CPB). In most cases, protamine is given in amounts sufficient to neutralize...
Eligibility Criteria
Inclusion
- First intention, elective, cardiac surgery: either Coronary Artery Bypass Graft (CABG)or valve repair/replacement.
- Patients on preoperative aspirin, clopidogrel or heparin will be included.
Exclusion
- Combination of CABG and valve surgery
- Second intention cardiac surgery
- ASA 5 patients
- Pre-existing hemostatic disorder (as evidenced by history)
- Pregnancy
- PLavix \< 5 days before de surgery
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00684450
Start Date
June 1 2008
End Date
June 1 2011
Last Update
August 25 2011
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8