Status:
TERMINATED
Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administrati...
Eligibility Criteria
Inclusion
- Signature of the consent form
- Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments)
Exclusion
- Absence of signature of the consent form
- Patient with cirrhosis
- Minor hepatectomy (\< 3 hepatic segments)
- Hepatectomy associated with vascular resection
- Contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection
- Pregnant or lactation
Key Trial Info
Start Date :
August 20 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00657384
Start Date
August 20 2008
End Date
November 1 2013
Last Update
March 1 2021
Active Locations (4)
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1
CHU Amiens, Hôpital Nord
Amiens, France, 80054
2
Chirurgie digestive et transplantation, Hôpital de Besançon
Besançon, France
3
CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)
Bordeaux, France, 33000
4
Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg
Strasbourg, France, 67098