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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00657384
Other study ID # 3959
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date August 20, 2008
Est. completion date November 2013

Study information

Verified date February 2021
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 130
Est. completion date November 2013
Est. primary completion date August 20, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
France CHU Amiens, Hôpital Nord Amiens
France Chirurgie digestive et transplantation, Hôpital de Besançon Besançon
France CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André) Bordeaux
France Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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