Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study

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).

Study Overview

• Status: Terminated
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Drug: acid tranexamic; Drug: Nacl 0.9%

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens, Hôpital Nord
  • Besançon, France
    • Chirurgie digestive et transplantation, Hôpital de Besançon
  • Bordeaux, France, 33000
    • CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)
  • Strasbourg, France, 67098
    • Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acid tranexamic	Drug: acid tranexamic; 10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention.
Placebo Comparator: 2; Nacl 0.9%	Drug: Nacl 0.9%; 10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Patrick Pessaux, CHU Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2008
• Primary Completion (Actual): August 20, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: April 8, 2008
• First Submitted That Met QC Criteria: April 10, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Specify the primary condition or disease being studied Major Hepatectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 3959