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

Civil Hospices of Lyon

Status: Completed

Conditions: Liver Transplantation

Treatments: Procedure: Rotem analysis; Procedure: Conventional coagulation profile Analysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02352181

2014-870

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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, ...)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups, including a placebo group

S group

Placebo Comparator group

Description:

S Group: will be transfused patients according to standard management based on conventional coagulation profile of the laboratory

Treatment:

Procedure: Conventional coagulation profile Analysis

R group

Experimental group

Description:

The R group will consist of patients transfused according to an algorithm based on the data of the coagulation ROTEM analysis.

Treatment:

Procedure: Rotem analysis