Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00657384
• Collaborator: (none)
• Enrollment: 130
• Locations: 4
• Arms: 2
• Actual Duration (Months): 62.4
• Patients Per Site: 32.5
• Patients Per Site Per Month: 0.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Blood Loss, Surgical	Drug: acid tranexamic; Drug: Nacl 0.9%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study
• Actual Study Start Date: Aug 20, 2008
• Actual Primary Completion Date: Aug 20, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: acid tranexamic acid tranexamic	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.
Placebo Comparator: 2 Nacl 0.9%	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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens, Hôpital Nord	Amiens		France	80054
2	Chirurgie digestive et transplantation, Hôpital de Besançon	Besançon		France
3	CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)	Bordeaux		France	33000
4	Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg	Strasbourg		France	67098

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Patrick Pessaux, CHU strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT00657384
• Other Study ID Numbers: 3959
• First Posted: Apr 14, 2008
• Last Update Posted: Mar 1, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by University Hospital, Strasbourg, France: Specify the primary condition or disease being studied Major Hepatectomy
• Additional relevant MeSH terms: Blood Loss, Surgical; Tranexamic Acid

Study Results

No Results Posted as of Mar 1, 2021