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Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

Primary Purpose

Blood Loss, Surgical

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

acid tranexamic

Nacl 0.9%

About this trial

This is an interventional prevention trial for Blood Loss, Surgical focused on measuring Specify the primary condition or disease being studied Major Hepatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

acid tranexamic

Arm Description

acid tranexamic

Nacl 0.9%

Outcomes

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%).

Secondary Outcome Measures

Full Information

NCT ID

NCT00657384

First Posted

April 8, 2008

Last Updated

February 24, 2021

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00657384

Brief Title

Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

Official Title

Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

insufficient recruitment

Study Start Date

August 20, 2008 (Actual)

Primary Completion Date

August 20, 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Loss, Surgical

Keywords

Specify the primary condition or disease being studied Major Hepatectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acid tranexamic

Arm Type

Experimental

Arm Description

acid tranexamic

Arm Title

Arm Type

Placebo Comparator

Arm Description

Nacl 0.9%

Intervention Type

Drug

Intervention Name(s)

acid tranexamic

Intervention Description

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

Intervention Name(s)

Nacl 0.9%

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

at day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Pessaux

Organizational Affiliation

CHU strasbourg

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Amiens, Hôpital Nord

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

Chirurgie digestive et transplantation, Hôpital de Besançon

City

Besançon

Country

France

Facility Name

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

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg

City

Strasbourg

ZIP/Postal Code

67098

Country

France

12. IPD Sharing Statement

Learn more about this trial

Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

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