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

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

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

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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

Resource links provided by the National Library of Medicine


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.





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.



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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, ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352181


Locations
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France
Hôpital de la Croix Rousse
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
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Principal Investigator: Aurélie Bonnet, PH Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02352181    
Other Study ID Numbers: 2014-870
First Posted: February 2, 2015    Key Record Dates
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:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders