Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 3

Conditions: Blood Loss, Surgical

Treatments: Drug: Nacl 0.9%; Drug: acid tranexamic

Study type: Interventional

Funder types: Other

Identifiers

NCT00657384

3959

Details and patient eligibility

About

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).

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

acid tranexamic

Experimental group

Description:

acid tranexamic

Treatment:

Drug: acid tranexamic

2

Placebo Comparator group

Description:

Nacl 0.9%

Treatment:

Drug: Nacl 0.9%