Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-20

Study Completion Date

2013-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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acid tranexamic

Group Type EXPERIMENTAL

acid tranexamic

Intervention Type 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

Nacl 0.9%

Group Type PLACEBO_COMPARATOR

Nacl 0.9%

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No