Perioperative Hemostasis Management in Liver Transplantation

NCT ID: NCT06257407

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-17

Study Completion Date

2026-03-01

Brief Summary

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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.

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.

Detailed Description

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Conditions

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Liver Transplant; Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults Patients with Liver transplant

No intervention during this observational study. Patient who meet the inclusion criteria will be included

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 or over
* Liver transplant patient

Exclusion Criteria

* Multi-organ transplantation
* Protected populations: under guardianship or curatorship
* Patients not affiliated to a social security scheme
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role collaborator

Société Française d'Anesthésie et de Réanimation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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WEISS, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Beaujon

Locations

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Chru Minjoz

Besançon, , France

Site Status RECRUITING

CHU Estaing

Clermont, , France

Site Status NOT_YET_RECRUITING

Hôpital Beaujon

Clichy, , France

Site Status NOT_YET_RECRUITING

CHU Grenoble Alpes

Grenoble, , France

Site Status NOT_YET_RECRUITING

CHU Claude Huriez

Lille, , France

Site Status RECRUITING

Hôpital de la Croix-Rousse

Lyon, , France

Site Status RECRUITING

CHU La Timone

Marseille, , France

Site Status NOT_YET_RECRUITING

Hôpital St Eloi

Montpellier, , France

Site Status NOT_YET_RECRUITING

Hôpital De L'Archet 2

Nice, , France

Site Status NOT_YET_RECRUITING

CHU Pitié-Salpêtrière

Paris, , France

Site Status NOT_YET_RECRUITING

CHU Haut Levêque

Pessac, , France

Site Status NOT_YET_RECRUITING

CHU Pontchaillou

Rennes, , France

Site Status NOT_YET_RECRUITING

CHU Hautepierre

Strasbourg, , France

Site Status NOT_YET_RECRUITING

CHU Toulouse Rangueil

Toulouse, , France

Site Status NOT_YET_RECRUITING

CHU Tours

Tours, , France

Site Status NOT_YET_RECRUITING

Hôpital Paul Brousse

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emmanuel WEISS, MD

Role: CONTACT

+33 1 40 87 58 81

Stéphanie ROULLET, MD

Role: CONTACT

+33 1 45 59 32 19

Facility Contacts

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Cyrielle DESPRES, MD

Role: primary

Renaud GUERIN, MD

Role: primary

Pauline DEVAUCHELLE, MD

Role: primary

Alexandre GODON, MD

Role: primary

Anne BIGNON, MD

Role: primary

Pierre JACQUENOD Pierre, MD

Role: primary

Benedicte GRIGORESCO, MD

Role: primary

Clément MONET, MD

Role: primary

Romain ROZIER Romain, MD

Role: primary

Antoine MONSEL, MD

Role: primary

Elsa DELOGE, MD

Role: primary

Axelle MAURICE, MD

Role: primary

Paul BRUNET, MD

Role: primary

Vincent ETIENNE, MD

Role: primary

Isaure BRETEAU, MD

Role: primary

Stephanie ROULLET, MD

Role: primary

Other Identifiers

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HEMOTRANSPLANT / 2022-12

Identifier Type: -

Identifier Source: org_study_id

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