Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

Phase 3

Terminated

• Conditions: Blood Loss, Surgical
• Interventions: Drug: acid tranexamic; Drug: Nacl 0.9%

• Registration Number: NCT00657384
• Lead Sponsor: University Hospital, Strasbourg, France

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 administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (\> 3 hepatic segments).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-14
• Study Start: 2008-08-20
• Primary Completion: 2013-08-20
• Study Completion: 2013-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Signature of the consent form
• Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acid tranexamic	acid tranexamic	acid tranexamic
2	Nacl 0.9%	Nacl 0.9%

Primary Outcome Measures

Name	Time	Method
The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%).	at day 5

Trial Locations

Locations (4)

CHU Amiens, Hôpital Nord; 🇫🇷 Amiens, France

Chirurgie digestive et transplantation, Hôpital de Besançon; 🇫🇷 Besançon, France

Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg; 🇫🇷 Strasbourg, France

CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André); 🇫🇷 Bordeaux, France