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Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00657384
Recruitment Status : Unknown
Verified September 2013 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : April 14, 2008
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Drug: acid tranexamic Drug: Nacl 0.9% Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study
Study Start Date : October 2008
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00657384     History of Changes
Other Study ID Numbers: 3959
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 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
Hemorrhage
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants