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

• ClinicalTrials.gov Identifier: NCT02352181
• Recruitment Status: Completed
• First Posted: February 2, 2015
• Last Update Posted: January 5, 2017
• Sponsor: Hospices Civils de Lyon
• Collaborator: Laboratoire français de Fractionnement et de Biotechnologies
• Information provided by (Responsible Party): Hospices Civils de Lyon

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Liver Transplantation	Procedure: Conventional coagulation profile Analysis; Procedure: Rotem analysis	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.
• Study Start Date: December 2014
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: S group; S Group: will be transfused patients according to standard management based on conventional coagulation profile of the laboratory	Procedure: 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).
Experimental: R group; The R group will consist of patients transfused according to an algorithm based on the data of the coagulation ROTEM analysis.	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.

Outcome Measures

Primary Outcome Measures :

1. Amount of blood product (in milliliter) transfused during liver transplantation. [ Time Frame: 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 :

1. Occurrence of serious respiratory complication. [ Time Frame: within 48 first hours after liver transplantation. ]
   reintubation; acute pulmonary oedema.
2. Occurrence of thrombotic complication. [ Time Frame: within 48 first hours after liver transplantation. ]
   hepatic artery thrombosis, sus hepatic thrombotic, portal thrombosis.
3. Occurrence of serious infectious complication [ Time Frame: within 48 first hours after liver transplantation. ]
   septic shock; serious sepsis, intubation necessity for sepsis.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, ...)

Contacts and Locations

Locations

France

Hôpital de la Croix Rousse

Lyon, France

Sponsors and Collaborators

Hospices Civils de Lyon

Laboratoire français de Fractionnement et de Biotechnologies

Investigators

• Principal Investigator: Aurélie Bonnet, PH; Hospices Civils de Lyon

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02352181
• Other Study ID Numbers: 2014-870
• First Posted: February 2, 2015
• Last Update Posted: January 5, 2017
• Last Verified: January 2017

Keywords provided by Hospices Civils de Lyon:

Cirrhosis, transplantation, transfusion, Rotem®

Additional relevant MeSH terms:

Hemostatic Disorders; Blood Coagulation Disorders; Hematologic Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders