Clinical trial NCT02352181: Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.
Official title: Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Keywords: Cirrhosis, transplantation, transfusion, Rotem®
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Laboratoire français de Fractionnement et de Biotechnologies
First posted: 2015-02-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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, ...)

Primary outcomes:
measure: Amount of blood product (in milliliter) transfused during liver transplantation.
timeFrame: During time of liver transplantation an average of 9 hours.
Secondary outcomes:
measure: Occurrence of serious respiratory complication.
timeFrame: within 48 first hours after liver transplantation.
measure: Occurrence of thrombotic complication.
timeFrame: within 48 first hours after liver transplantation.
measure: Occurrence of serious infectious complication
timeFrame: within 48 first hours after liver transplantation.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Aurélie Bonnet, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnet A, Gilquin N, Steer N, Gazon M, Quattrone D, Pradat P, Maynard M, Mabrut JY, Aubrun F. The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study. Eur J Anaesthesiol. 2019 Nov;36(11):825-833. doi: 10.1097/EJA.0000000000001084.