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Liver Transplant; ComplicationsHEMOTRANSPLANTNCT06257407

Perioperative Hemostasis Management in Liver Transplantation

An observational study of Liver Transplant; Complications, run by Société Française d'Anesthésie et de Réanimation at 16 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Liver transplantation (LT) is a surgery with risk of bleeding. Several risk factors have been identified: complex dissection, portal hypertension, history of ascites fluid infections, history of surgical procedures, pre-existing complex hemostatic disorders and those acquired during the procedure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Transplant; Complications
How many people
1,200 participants
Where
16 sitesFrance
Study dates
17 Oct 2024to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Liver transplant patient

Who may be able to join

  • Patients aged 18 or over
  • Liver transplant patient

Who cannot join

  • Multi-organ transplantation
  • Protected populations: under guardianship or curatorship
  • Patients not affiliated to a social security scheme

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emmanuel WEISS, MD contact

+33 1 40 87 58 81

emmanuel.weiss@aphp.fr

Stéphanie ROULLET, MD contact

+33 1 45 59 32 19

stephanie.roullet@aphp.fr

16 sites in 1 country

France16 sites, 16 recruiting

  • Chru Minjoz

    Besançon

    Cyrielle DESPRES, MD

    Recruiting

  • CHU Estaing

    Clermont

    Renaud GUERIN, MD

    Not yet recruiting

  • Hôpital Beaujon

    Clichy

    Pauline DEVAUCHELLE, MD

    Not yet recruiting

  • CHU Grenoble Alpes

    Grenoble

    Alexandre GODON, MD

    Not yet recruiting

  • CHU Claude Huriez

    Lille

    Anne BIGNON, MD

    Recruiting

  • Hôpital de la Croix-Rousse

    Lyon

    Pierre JACQUENOD Pierre, MD

    Recruiting

  • CHU La Timone

    Marseille

    Benedicte GRIGORESCO, MD

    Not yet recruiting

  • Hôpital St Eloi

    Montpellier

    Clément MONET, MD

    Not yet recruiting

  • Hôpital De L'Archet 2

    Nice

    Romain ROZIER Romain, MD

    Not yet recruiting

  • CHU Pitié-Salpêtrière

    Paris

    Antoine MONSEL, MD

    Not yet recruiting

  • CHU Haut Levêque

    Pessac

    Elsa DELOGE, MD

    Not yet recruiting

  • CHU Pontchaillou

    Rennes

    Axelle MAURICE, MD

    Not yet recruiting

  • CHU Hautepierre

    Strasbourg

    Paul BRUNET, MD

    Not yet recruiting

  • CHU Toulouse Rangueil

    Toulouse

    Vincent ETIENNE, MD

    Not yet recruiting

  • CHU Tours

    Tours

    Isaure BRETEAU, MD

    Not yet recruiting

  • Hôpital Paul Brousse

    Villejuif

    Stephanie ROULLET, MD

    Recruiting

Other trials in France

About this study

Liver transplantation (LT) is a surgery with risk of bleeding. Several risk factors have been identified: complex dissection, portal hypertension, history of ascites fluid infections, history of surgical procedures, pre-existing complex hemostatic disorders and those acquired during the procedure. Diffuse bleeding can occur at any time during the 3 phases of surgery: dissection, anhepatic and neohepatic. However, intraoperative bleeding and transfusion requirements remain difficult to predict. Current predictive models are based in particular on preoperative characteristics and do not take into account the course and different phases of the operation.

The need for transfusions has largely decreased over the last 20 years, and currently around 20-25% of patients are transfused (transfusion of at least 1 blood product during LT). However, massive transfusion is necessary in 10% of LT. The European Society of Anaesthesiology (ESA) has issued recommendations on the management of severe bleeding during surgery. However, these recommendations are not specific to LT. Moreover, transfusion strategies vary widely from one center to another. The implementation of protocols within teams dedicated to LT has led to a reduction in bleeding and transfusion, with or without the use of viscoelastic testing.

Read more

Intraoperative bleeding and transfusion requirements, as well as postoperative thromboembolic complications, remain difficult to predict. Predictive models of bleeding risk have been developed, but they are based solely on preoperative characteristics and do not take into account the course and various phases of the operation. In addition, new methods such as Bayesian inference or machine learning have been developed, and seem capable of providing different information from that obtained by conventional models.

The overall aim of this prospective multicenter observational study is to investigate the risk factors for bleeding and thrombosis in per- and post-operative LT using different predictive methods, and to describe the management of bleeding and post-operative anticoagulation in metropolitan France.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06257407
Study groupRoleWhat they receive
Adults Patients with Liver transplantNo intervention during this observational study. Patient who meet the inclusion criteria will be included

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT

    Number of intraoperative pRBCs transfused

    Measured: number of pRBCs transfused during surgery

Secondary outcomes (13)

  1. Determine factors predicting transfusion of more than 2 pRBCs intraoperatively

    (qualitative binary) transfusion of more than 2 intraoperative RBCs (Y/N)

    Measured: During surgery

  2. Determine the predictive factors for intraoperative transfusion of RBCs for LT

    (qualitative binary) intraoperative use of packed red blood cells (Y/N)

    Measured: During surgery

  3. Determine the predictive factors of the number of RBCs transfused at each phase of LT

    (quantitative) number of pRBCs transfused during each of the 3 phases of LT

    Measured: During surgery

  4. Determine factors predicting intraoperative bleeding volume in LT

    intraoperative bleeding volume

    Measured: During surgery

  5. Determine haemoglobin mass loss in patients not receiving intraoperative pRBC transfusion of LT

    Haemoglobin mass loss

    Measured: During surgery

  6. Describe haemostatic tests (conventional biological and viscoelastic) carried out intraoperatively on LT. By listing all haemostatic tests performed

    Haemostatic tests performed

    Measured: During surgery

  7. Describe the use of blood products, blood-derived medicinal products and antifibrinolytics administered during each phase of LT and during the first 24 hours postoperatively. By listing all products administered.

    Blood products, blood-derived medicinal products, antifibrinolytics

    Measured: During surgery

  8. Determine the factors predicting the number of RBCs transfused within 24 hours post-LT

    (quantitative) number of RBCs transfused in the 24 hours post-LT

    Measured: During 24 hours post-LT

  9. To explore the links between bleeding or transfusion and the results of haemostatic tests (conventional biological and viscoelastic) in peri-operative LT. By comparing occurance of bleeding or transfusion and values of haemostatic tests.

    Results of haemostatic tests performed after bleeding or transfusion

    Measured: During operation

  10. Describe the post-operative use of anti-aggregants and anticoagulants drugs in LT

    Listing of Antiaggregation and thromboprophylaxis used

    Measured: During the first 30 days postoperative LT

  11. Describe postoperative venous thrombotic events (deep vein thrombosis, pulmonary embolism, portal thrombosis) and arterial (graft artery thrombosis) during the first 30 days postoperative LT

    Thrombotic complications

    Measured: During the first 30 days postoperative LT

  12. Measure the possible effect of the various pro- and antihaemostatic treatments on haemorrhagic and thrombotic complications in the first 30 days after LT surgery

    Thrombotic complications and haemorrhagic complications

    Measured: During the first 30 days postoperative LT

  13. Explore the links between thombothic events and the results of hemostatic tests (common biological tests and viscoelastic tests)

    Results of hemostatic tests performed during thrombothic events

    Measured: thombotic events observed during the first 30 days postoperative LT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start17 Oct 2024
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257407
Sponsor's protocol ID
HEMOTRANSPLANT / 2022-12
Acronym
HEMOTRANSPLANT
Status last verified
Mar 2026
First submitted
31 Jan 2024
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Transplant; Complications, run by Société Française d'Anesthésie et de Réanimation at 16 sites 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emmanuel WEISS, MD (+33 1 40 87 58 81, emmanuel.weiss@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT (time frame: number of pRBCs transfused during surgery). 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 NCT06257407.

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 2 Apr 2026.

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