Status:
UNKNOWN
Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery
Lead Sponsor:
German Heart Center
Conditions:
Bleeding and Cardiac Surgery
Allogeneic Blood Transfusion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac ...
Detailed Description
Excessive bleeding during and after cardiac surgery is a serious complication. It exposes patients to the risk of allogeneic blood transfusion or other blood products and the risk of mediastinal re-ex...
Eligibility Criteria
Inclusion
- informed consent
- Patients undergoing primary CABG or Aortic valve replacement surgery
Exclusion
- Previous sternotomy
- OPCAB surgery
- urgent/emergency operation
- Coumadin treatment
- previous aprotinin exposure
- preoperative renal impairment (Creatinine \> 2 mg/dL)
- patients refusing blood transfusions
- no informed consent
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00396760
Start Date
January 1 2005
End Date
July 1 2006
Last Update
November 7 2006
Active Locations (1)
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1
German Heart Center Munich
Munich, Munich, Germany, 80636