Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

NCT00657384 | Terminated Phase 3

• 1 other identifier: 3959
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 4

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).

Conditions

Blood Loss, Surgical

Keywords

Specify the primary condition or disease being studied Major Hepatectomy

Outcome Measures

Primary Outcomes (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%).

  at day 5

Study Arms (2)

acid tranexamic

EXPERIMENTAL

acid tranexamic

Drug: acid tranexamic

2

PLACEBO COMPARATOR

Nacl 0.9%

Drug: Nacl 0.9%

Interventions

acid tranexamic DRUG

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.

acid tranexamic

Nacl 0.9% DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of the consent form
• Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (4)

CHU Amiens, Hôpital Nord

Amiens, 80054, France

Location

Chirurgie digestive et transplantation, Hôpital de Besançon

Besançon, France

Location

CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)

Bordeaux, 33000, France

Location

Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Patrick Pessaux

  CHU strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: August 20, 2008
• Primary Completion: August 20, 2013
• Study Completion: November 1, 2013
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

FR (4)