- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02352181
Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France
- Hopital de la Croix Rousse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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 :
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.
|
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 :
Bolus Tranexamic acid 1g and 3g every 24 hours :
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During time of liver transplantation an average of 9 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of serious respiratory complication.
Time Frame: within 48 first hours after liver transplantation.
|
reintubation; acute pulmonary oedema.
|
within 48 first hours after liver transplantation.
|
Occurrence of thrombotic complication.
Time Frame: within 48 first hours after liver transplantation.
|
hepatic artery thrombosis, sus hepatic thrombotic, portal thrombosis.
|
within 48 first hours after liver transplantation.
|
Occurrence of serious infectious complication
Time Frame: within 48 first hours after liver transplantation.
|
septic shock; serious sepsis, intubation necessity for sepsis.
|
within 48 first hours after liver transplantation.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aurélie Bonnet, PH, Hospices Civils de Lyon
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-870
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Transplantation
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCzechia, France, Italy, Poland, United Kingdom
-
The Hospital for Sick ChildrenCompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCanada
-
Astellas Pharma Europe Ltd.TerminatedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationSpain, Australia, France, Germany, Canada, Italy, United Kingdom, Belgium, South Africa, Switzerland, Sweden, United States, Austria, Brazil, Czechia, Denmark, Finland, Hungary, Ireland, Mexico, Netherlands, New Zealand, Poland
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
Astellas Pharma Europe Ltd.Active, not recruitingLiver Transplantation | Kidney Transplantation | Heart Transplantation | Lung Transplantation | Intestine TransplantationBelgium, Czechia, France, Germany, Italy, Poland, United Kingdom
-
NovartisCompletedLiver Transplantation | Kidney TransplantationSwitzerland
-
University of Wisconsin, MadisonTerminatedLiver Transplantation | Kidney TransplantationUnited States
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingLiver Transplantation | Kidney TransplantationFrance
-
Astellas Pharma China, Inc.CompletedLiver Transplantation | Kidney TransplantationChina
Clinical Trials on Conventional coagulation profile Analysis
-
Sohag UniversityCompleted
-
Sohag UniversityRecruitingRare Inherited Bleeding Disorders in Children at Sohag University HospitalEgypt
-
University Hospital, GhentActive, not recruitingThrombosis | Bleeding Disorder | Extra Corporeal Life SupportBelgium, Germany
-
University of PecsUnknownPerioperative/Postoperative Complications | Abdominal Aortic Aneurism | Abdominal Aortic Rupture | Surgical Blood Loss
-
Sohag UniversityNot yet recruiting
-
Hasselt UniversityKU Leuven; Jessa Hospital; Ziekenhuis Oost-Limburg; Algemeen Ziekenhuis Vesalius; Zuyd University of Applied Sciences and other collaboratorsCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...Active, not recruiting
-
University Hospital, BordeauxHoffmann-La Roche; Ministry of Health, France; BiodisCompletedMechanical Prosthetic Heart Valve Implantation | Patient Self Monitoring of Oral Anticoagulent TherapyFrance
-
Sohag UniversityNot yet recruitingRespiratory IllnessesEgypt
-
GeneCast Biotechnology Co., Ltd.The First Affiliated Hospital of Air Force Military Medical University (Xijing...Recruiting