Status:
COMPLETED
Dose-ranging Study of Two Doses of Tranexamic Acid During Cardiac Surgery
Lead Sponsor:
Hopital Foch
Conditions:
Cardiopulmonary Bypass
Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Cardiac surgery with CardioPulmonary Bypass (CPB) exposes to per and postoperative bleeding, and may lead to allogenic blood transfusion re-intervention and many adverse outcomes. Prophylactic use of ...
Eligibility Criteria
Inclusion
- Any type of cardiac surgical procedure requiring CPB (including coronary artery bypass grafting, valve repair or replacement, aortic surgery, endocarditis).
Exclusion
- Emergency surgery, age \< 18 years old, pregnancy, history of allergy to TA, history of seizure or thromboembolism event, history of previous antifibrinolytic or thrombolytic therapy within 5 days of surgery, coagulation disorder, liver disease, renal failure (clearance \< 30 ml/min), Jehovah witness.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00809393
Start Date
February 1 2009
End Date
January 1 2011
Last Update
September 23 2016
Active Locations (4)
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1
department of anaesthesiology, CHU Jean Minjoz
Besançon, France, 25030
2
department of anesthesiology, Haut Leveque Hospital
Bordeaux, France
3
department of anesthesiology, Bichat Hospital
Paris, France, 75018
4
Hopital Foch
Suresnes, France, 92150