Text Size

Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00657384
First received: April 8, 2008
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Blood Loss, Surgical
 Drug: acid tranexamic
Drug: Nacl 0.9%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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%). [ Time Frame: at day 5 ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: October 2008
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acid tranexamic
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657384

Contacts
Contact: Patrick Pessaux, MD 00333.88.12.72.59 patrick.pessaux@chru-strasbourg.fr

Locations
France
CHU Amiens, Hôpital Nord Not yet recruiting
Amiens, France, 80054
Contact: REGIMBEAU Jean-Marc, MD     03.22.66.79.28     Regimbeau.jean-marc@chu-amiens.fr    
Contact: FUKS David, MD     03.22.66.83.00     fuks.david@chu-amiens.fr    
Principal Investigator: REGIMBEAU Jean-Marc, MD            
Sub-Investigator: FUKS David, MD            
Chirurgie digestive et transplantation, Hôpital de Besançon Not yet recruiting
Besançon, France
Contact: Bruno Heyd, MD     00333.81.66.89.70     Bruno.heyd@univ-fcomte.fr    
Principal Investigator: Bruno Heyd, MD            
Sub-Investigator: Delphine Delroeux, MD            
Sub-Investigator: Pierre Morati, MD            
Sub-Investigator: Emmanuel Samain, MD            
CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André) Not yet recruiting
Bordeaux, France, 33000
Contact: SA CUNHA Antonio, MD     05.57.65.60.05     antonio.sa-cunha@chu-bordeaux.fr    
Contact: SARIC Jean, MD     05.57.82.06.18     Jean.saric@chu-bordeaux.fr    
Principal Investigator: CUNHA Antonio, MD            
Sub-Investigator: LAURENT Christophe, MD            
Principal Investigator: SARIC Jean, MD            
Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Patrick Pessaux, MD     00333.88.12.72.59     Patrick.pessaux@chru-strasbourg.fr    
Principal Investigator: Patrick Pessaux, MD            
Sub-Investigator: Daniel Jaeck, MD            
Sub-Investigator: Philippe Bachelier, MD            
Sub-Investigator: Philippe Wolf, MD            
Sub-Investigator: Elie Oussoultozoglou, MD            
Sub-Investigator: Catherine Cuby, MD            
Sub-Investigator: Catherine Lehmann, MD            
Sub-Investigator: Olivier Collange, MD            
Sub-Investigator: Edoardo Rosso, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Patrick Pessaux CHU strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00657384     History of Changes
Other Study ID Numbers: 3959
Study First Received: April 8, 2008
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
Specify the primary condition or disease being studied Major Hepatectomy

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013