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

NACompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

August 31, 2016

Study Completion Date

November 30, 2016

Conditions
Liver Transplantation
Interventions
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."

Trial Locations (1)

Unknown

Hôpital de la Croix Rousse, Lyon

All Listed Sponsors
collaborator

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

lead

Hospices Civils de Lyon

OTHER

NCT02352181 - Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment. | Biotech Hunter | Biotech Hunter