Status:
COMPLETED
AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Cardiac Surgery
Cardiopulmonary Bypass
Eligibility:
All Genders
18+ years
Brief Summary
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe pe...
Detailed Description
Perioperative bleeding remains a real challenge for physicians managing cardiac surgical patients. In patients at high risk for excessive bleeding the prophylactic use of antifibrinolytics may be usef...
Eligibility Criteria
Inclusion
- patients undergoing cardiac on pump surgery at high risk for bleeding defined by :
- Aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (Primary or redo)
- Heart transplant (Primary or Redo)
- Infectious endocarditis (Primary or Redo)
- Ascending acute aortic dissection (Primary or Redo)
- Artificial heart / LVAD under CEC (Primary or Redo)
- Combined surgery, Redo
- Ascending aorta surgery, Redo
Exclusion
- Off pump cardiac surgery
- Patient not meeting the inclusion criteria
- Patient not receiving antifibrinolytic therapy
- Patient with absolute contraindication to antifibrinolytics,
- Patient refusing to give access to their medical chart,
- Patient not meeting the inclusion criteria
- Patient protected by the law, under guardianship or trusteeship,
- Patient deprived of liberty
Key Trial Info
Start Date :
March 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
693 Patients enrolled
Trial Details
Trial ID
NCT04804345
Start Date
March 31 2021
End Date
August 31 2021
Last Update
March 3 2022
Active Locations (7)
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1
Grenoble University Hospital
La Tronche, France, 38700
2
Lyon University Hospital
Lyon, France, 69500
3
Montpellier University Hospital
Montpellier, France, 34295
4
Nantes University Hospital
Nantes, France, 44093