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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352181
• Other study ID #: 2014-870
• Status: Completed
• Phase: N/A
• First received: December 18, 2014
• Last updated: January 4, 2017
• Start date: December 2014
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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, ...)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Liver Transplantation

Intervention

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).
• 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.

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Laboratoire français de Fractionnement et de Biotechnologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of blood product (in milliliter) transfused during liver transplantation.	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.	During time of liver transplantation an average of 9 hours.	No
Secondary	Occurrence of serious respiratory complication.	reintubation; acute pulmonary oedema.	within 48 first hours after liver transplantation.	No
Secondary	Occurrence of thrombotic complication.	hepatic artery thrombosis, sus hepatic thrombotic, portal thrombosis.	within 48 first hours after liver transplantation.	No
Secondary	Occurrence of serious infectious complication	septic shock; serious sepsis, intubation necessity for sepsis.	within 48 first hours after liver transplantation.	No