NCT02352181.

Trial name or title	Management of coagulopathy during orthotopic liver transplantation. Comparison between ROTEM‐based management and standard biological assessment
Methods	Randomized parallel assignment, open‐label Estimated enrolment: 80
Participants	Inclusion criteria: 1. patients >= 18 years of age 2. 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 participation in the study 3. patients affiliated to a social security system or similar 4. patients not subject to a measure of legal protection Exclusion criteria: 1. opposition to participation in the study 2. patients < 18 years of age 3. patients who participated in the previous month in another study protocol 4. pregnant women or breastfeeding 5. not affiliated with a social security system 6. patients with haemostasis pathology (haemophilia)
Interventions	Experimental: R group The R group will consist of patients transfused according to an algorithm based on the data of the coagulation ROTEM analysis Transfusional protocol for ROTEM group. RBC concentrate if haemoglobin < 9 gram per litre; fibrinogen 3 gram, if A10 FIBTEM < 8 mm Platelet concentrate: 1. if MCF EXTEM < 40 mm or A10 < 35 mm and MCF or A10 FIBTEM > 8 mm 2. if platelets < 30 gram per litre at vascular unclamping time at the end of intervention or without bleeding. 2 FFP if CT EXTEM >100s Bolus tranexamic acid 1 g and 3 g every 24 hours: 1. if fibrinolysis in EXTEM 2. reduction of 15% of clotting time or clot formation time and increase of MCF 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) 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 RBC concentrate if haemoglobin < 9 gram per litre; fibrinogen 3 gram, if fibrinogen < 1 gram per litre Platelet concentrate: 1. if platelets < 50 gram per litre before transfusion, at anhepatic phase, or in case of bleeding 2. if platelets < 30 gram per litre at vascular unclamping time at the end of intervention or without bleeding; 2 FFP if: prothrombin < 40% before transfusion at anhepatic phase or in case of bleeding prothrombin < 30% at vascular unclamping time at the end of intervention or without bleeding bolus tranexamic acid 1 g and 3 g every 24 hours in case of fibrin degradation product Analyses in S group only: coagulation profile (PT, aPTT, INR, fibrinogen, platelet count, soluble complexes, PDF) Analyses common to both groups: NFS, chemistry panel with ionised serum calcium, blood gas with lactates, HemoCue, capillary blood glucose
Outcomes	Primary outcome measures: amount of blood product (in millilitre) transfused during liver transplantation, during time of liver transplantation an average of 9 hours Secondary outcome measures: (within first 48 hours after liver transplantation). Occurrence of serious respiratory complication, reintubation, acute pulmonary oedema, occurrence of thrombotic complication, hepatic artery thrombosis, portal thrombosis Occurrence of serious infectious complication, septic shock; serious sepsis, intubation necessity for sepsis
Starting date	Starting December 2014 and estimated study completion October 2017
Contact information	Contact: Aurélie Bonnet, aurelie.bonnet@chu‐lyon.fr, Isabelle Delfour isabelle.delfour@chu‐lyon.fr, Hôpital de la Croix Rousse, Lyon, France
Notes	NCT02352181