Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.

Not Applicable

Completed

• Conditions: Liver Transplantation
• Interventions: Procedure: Conventional coagulation profile Analysis; Procedure: Rotem analysis

• Registration Number: NCT02352181
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

In current practice, management of coagulation during liver transplantation is performed either through standard coagulation status or with ROTEM® depending on practitioner choice and availability of materials. In this context, the ROTEM® is used since over 2 years by anesthesiologists in the digestive surgery department of the Croix Rousse hospital in Lyon, France.

Indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy developed by patients who are eligible, due to coagulation factor synthesis deficiencies in the cirrhotic liver. On the other hand the standard coagulation profile is a poor reflection of coagulopathy in such patients because the imbalance between pro- and anti-coagulant factors are not taken into account by PT and aPTT measures. Management of intraoperative hemorrhage may be facilitated by the ROTEM® which is performed from whole blood and which allows the detection of abnormalities in the balance between pro- and anti-coagulant factors.

This technique was already evaluated in liver, cardiac, and obstetric surgery but also in traumatology. Randomized trials in liver transplantation surgery have shown changes in transfusion practices but did not focus on the consequences of such changes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-02-02
• Primary Completion: 2016-08
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patients >=18 years of age
• Patients undergoing orthotopic liver transplantation in the Croix-Rousse Hospital within 24 months after inclusion and who have received clear information and who are not opposed to the participation in the study
• Patients affiliated to a social security system or similar
• Patients not subject to a measure of legal protection

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Exclusion Criteria

• Opposition to participation in the study
• Patients <18 years of age
• Patients who participated in the previous month to another study protocol
• Pregnant women or breast-feeding
• Not affiliated to a social security system
• Patients with hemostasis pathology (hemophilia, ...)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S group	Conventional coagulation profile Analysis	S Group: will be transfused patients according to standard management based on conventional coagulation profile of the laboratory
R group	Rotem analysis	The R group will consist of patients transfused according to an algorithm based on the data of the coagulation ROTEM analysis.

Primary Outcome Measures

Name	Time	Method
Amount of blood product (in milliliter) transfused during liver transplantation.	During time of liver transplantation an average of 9 hours.	Assessing the impact of intraoperative management of coagulation by ROTEM® compared to the conventional management (standard coagulation profile) on the amount of blood product units (in milliliter) transfused during liver transplantation.

Secondary Outcome Measures

Name	Time	Method
Occurrence of serious respiratory complication.	within 48 first hours after liver transplantation.	reintubation; acute pulmonary oedema.
Occurrence of thrombotic complication.	within 48 first hours after liver transplantation.	hepatic artery thrombosis, sus hepatic thrombotic, portal thrombosis.
Occurrence of serious infectious complication	within 48 first hours after liver transplantation.	septic shock; serious sepsis, intubation necessity for sepsis.

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France