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

NCT ID: NCT02352181

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-11-30

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.

Conditions

Liver Transplantation

Keywords

Cirrhosis, transplantation, transfusion, Rotem®

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

S group

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

Group Type: PLACEBO_COMPARATOR

Conventional coagulation profile Analysis

Intervention Type: PROCEDURE

Transfusional protocol for Standard group Red Blood cells concentrate if Hemoglobin <9 gram per liter Fibrinogen 3 gram, if fibrinogen <1gram per liter

Platelet concentrate :

• if platelets <50gram per liter before transfusion, at anhepatic phase, or in case of bleeding.
• if platelets <30gram per liter at vascular unclamping time at the end of intervention or without bleeding 2 Fresh frozen plasma if :
• if prothrombin<40% before transfusion at anhepatic phase or in case of bleeding.
• if prothrombin<30% at vascular unclamping time at the end of intervention or without bleeding Bolus Tranexamic acid 1g and 3g every 24 hours in case of fibrin degradation products.

Analyses common to both groups: NFS, chemistry panel with ionized serum calcium, blood gas with lactates, HemoCue ®, capillary blood glucose.

Analyses in S Group only: coagulation profile (PT, APTT, INR, fibrinogen, platelet count, soluble complexes, PDF).

R group

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

Group Type: EXPERIMENTAL

Rotem analysis

Intervention Type: PROCEDURE

Transfusional protocol for Rotem group. Red Blood cells concentrate if Hemoglobin <9 gram per liter Fibrinogen 3 gram, if A10 FIBTEM <8 mm

Platelet concentrate :

• If MCF EXTEM <40mm or A10<35 mm and MCF or A10 FIBTEM >8mm.
• If platelets <30gram per liter at vascular unclamping time at the end of intervention or without bleeding.

2 Fresh frozen plasma if CT EXTEM >100s.

Bolus Tranexamic acid 1g and 3g every 24 hours :

• if fibrinolysis in EXTEM
• Reduction of 15 % of clotting time or clot formation time and increase of maximum clot firmness in APTEM compared to EXTEM, or maximal lysis at 60 minutes >15%.

Analyses in R group only: blood sampling on citrated tube for ROTEM analysis (EXTEM, INTEM, FIBTEM, APTEM +/- HEPTEM), coagulation profile (same as that of the S Group, for emergency procedure).

Analyses common to both groups: NFS, chemistry panel with ionized serum calcium, blood gas with lactates, HemoCue ®, capillary blood glucose.

Interventions

Conventional coagulation profile Analysis

Transfusional protocol for Standard group Red Blood cells concentrate if Hemoglobin <9 gram per liter Fibrinogen 3 gram, if fibrinogen <1gram per liter

Platelet concentrate :

• if platelets <50gram per liter before transfusion, at anhepatic phase, or in case of bleeding.
• if platelets <30gram per liter at vascular unclamping time at the end of intervention or without bleeding 2 Fresh frozen plasma if :
• if prothrombin<40% before transfusion at anhepatic phase or in case of bleeding.
• if prothrombin<30% at vascular unclamping time at the end of intervention or without bleeding Bolus Tranexamic acid 1g and 3g every 24 hours in case of fibrin degradation products.

Analyses common to both groups: NFS, chemistry panel with ionized serum calcium, blood gas with lactates, HemoCue ®, capillary blood glucose.

Analyses in S Group only: coagulation profile (PT, APTT, INR, fibrinogen, platelet count, soluble complexes, PDF).

Intervention Type: PROCEDURE

Rotem analysis

Transfusional protocol for Rotem group. Red Blood cells concentrate if Hemoglobin <9 gram per liter Fibrinogen 3 gram, if A10 FIBTEM <8 mm

Platelet concentrate :

• If MCF EXTEM <40mm or A10<35 mm and MCF or A10 FIBTEM >8mm.
• If platelets <30gram per liter at vascular unclamping time at the end of intervention or without bleeding.

2 Fresh frozen plasma if CT EXTEM >100s.

Bolus Tranexamic acid 1g and 3g every 24 hours :

• if fibrinolysis in EXTEM
• Reduction of 15 % of clotting time or clot formation time and increase of maximum clot firmness in APTEM compared to EXTEM, or maximal lysis at 60 minutes >15%.

Analyses in R group only: blood sampling on citrated tube for ROTEM analysis (EXTEM, INTEM, FIBTEM, APTEM +/- HEPTEM), coagulation profile (same as that of the S Group, for emergency procedure).

Analyses common to both groups: NFS, chemistry panel with ionized serum calcium, blood gas with lactates, HemoCue ®, capillary blood glucose.

Intervention Type: PROCEDURE

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, ...)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie Bonnet, PH

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital de la Croix Rousse

Lyon, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 31567574 (View on PubMed)

Other Identifiers

2014-870

Identifier Type: -

Identifier Source: org_study_id