Liver TransplantationNCT02352181
Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.
A study testing Conventional coagulation profile Analysis and Rotem analysis in people with Liver Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Conventional coagulation profile Analysis and Rotem analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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, ...)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Conventional coagulation profile Analysis, Rotem analysis
- Keywords
- Cirrhosis, transplantation, transfusion, Rotem®
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional coagulation profile AnalysisProcedure or surgery
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).
Rotem analysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| S group | Placebo comparator | S Group: will be transfused patients according to standard management based on conventional coagulation profile of the laboratory Receives: Procedure: Conventional coagulation profile Analysis |
| R group | Experimental | The R group will consist of patients transfused according to an algorithm based on the data of the coagulation ROTEM analysis. Receives: Procedure: Rotem analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood product (in milliliter) transfused during liver transplantation.
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.
Measured: During time of liver transplantation an average of 9 hours.
Secondary outcomes (3)
Occurrence of serious respiratory complication.
reintubation; acute pulmonary oedema.
Measured: within 48 first hours after liver transplantation.
Occurrence of thrombotic complication.
hepatic artery thrombosis, sus hepatic thrombotic, portal thrombosis.
Measured: within 48 first hours after liver transplantation.
Occurrence of serious infectious complication
septic shock; serious sepsis, intubation necessity for sepsis.
Measured: within 48 first hours after liver transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies
- Responsible party
- Sponsor
- Investigators
- Aurélie Bonnet, PH, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352181
- Sponsor's protocol ID
- 2014-870
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonnet A, Gilquin N, Steer N, Gazon M, Quattrone D, Pradat P, Maynard M, Mabrut JY, Aubrun F. The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study. Eur J Anaesthesiol. 2019 Nov;36(11):825-833. doi: 10.1097/EJA.0000000000001084.
PubMed 31567574
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.
- ClinicalTrials.gov ID
- NCT02352181
- Acronym / sponsor ID
- 2014-870
- Conditions
- Liver Transplantation
- Keywords
- Cirrhosis, transplantation, transfusion, Rotem®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies
- Study start
- Dec 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S group | Placebo comparator | Procedure: Conventional coagulation profile AnalysisS Group: will be transfused patients according to standard management based on conventional coagulation profile of the laboratory |
| R group | Experimental | Procedure: Rotem analysisThe R group will consist of patients transfused according to an algorithm based on the data of the coagulation ROTEM analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional coagulation profile AnalysisTransfusional 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 or surgery | S group |
| Rotem analysisTransfusional 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. | Procedure or surgery | R group |
Primary outcome
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.
3 secondary outcomes
Occurrence of serious respiratory complication.
Time frame: within 48 first hours after liver transplantation.
Occurrence of thrombotic complication.
Time frame: within 48 first hours after liver transplantation.
Occurrence of serious infectious complication
Time frame: within 48 first hours after liver transplantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 31567574Bonnet A, Gilquin N, Steer N, Gazon M, Quattrone D, Pradat P, Maynard M, Mabrut JY, Aubrun F. The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study. Eur J Anaesthesiol. 2019 Nov;36(11):825-833. doi: 10.1097/EJA.0000000000001084.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie Bonnet, PH principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional coagulation profile Analysis and Rotem analysis in people with Liver Transplantation, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of blood product (in milliliter) transfused during liver transplantation. (time frame: During time of liver transplantation an average of 9 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02352181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.