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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00657384
First received: April 8, 2008
Last updated: September 6, 2013
Last verified: September 2013
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU Amiens, Hôpital Nord
Amiens, France, 80054
Chirurgie digestive et transplantation, Hôpital de Besançon
Besançon, France
CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)
Bordeaux, France, 33000
Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg
Strasbourg, France, 67098
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 
Study First Received: April 8, 2008
Last Updated: September 6, 2013
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:
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on December 05, 2016