NCT02352181

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).
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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-08-01
• Completion: 2016-11-01
• First posted: 2015-02-02
• Last updated: 2025-12-19

Locations

1 site across 1 country: France