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Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Hospital, Strasbourg, France Identifier:
First received: April 8, 2008
Last updated: September 6, 2013
Last verified: September 2013
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

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 ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00657384

Contact: Patrick Pessaux, MD 00333.

CHU Amiens, Hôpital Nord Not yet recruiting
Amiens, France, 80054
Contact: REGIMBEAU Jean-Marc, MD   
Contact: FUKS David, MD   
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.   
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   
Contact: SARIC Jean, MD   
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.   
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
Principal Investigator: Patrick Pessaux CHU strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00657384     History of Changes
Other Study ID Numbers: 3959
Study First Received: April 8, 2008
Last Updated: September 6, 2013

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

Additional relevant MeSH terms:
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants processed this record on May 25, 2017