Perioperative Hemostasis Management in Liver Transplantation

Last updated: October 31, 2024
Sponsor: Société Française d'Anesthésie et de Réanimation
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06257407
HEMOTRANSPLANT / 2022-12
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18 or over

  • Liver transplant patient

Exclusion

Exclusion Criteria:

  • Multi-organ transplantation

  • Protected populations: under guardianship or curatorship

  • Patients not affiliated to a social security scheme

Study Design

Total Participants: 1200
Study Start date:
October 17, 2024
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • Chru Minjoz

    Besançon,
    France

    Active - Recruiting

  • CHU Estaing

    Clermont,
    France

    Site Not Available

  • Hôpital Beaujon

    Clichy,
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble,
    France

    Site Not Available

  • CHU Claude Huriez

    Lille,
    France

    Active - Recruiting

  • Hôpital de la Croix-Rousse

    Lyon,
    France

    Active - Recruiting

  • CHU La Timone

    Marseille,
    France

    Site Not Available

  • Hôpital St Eloi

    Montpellier,
    France

    Site Not Available

  • Hôpital De L'Archet 2

    Nice,
    France

    Site Not Available

  • CHU Pitié-Salpêtrière

    Paris,
    France

    Site Not Available

  • CHU Haut Levêque

    Pessac,
    France

    Site Not Available

  • CHU Pontchaillou

    Rennes,
    France

    Site Not Available

  • CHU Hautepierre

    Strasbourg,
    France

    Site Not Available

  • CHU Toulouse Rangueil

    Toulouse,
    France

    Site Not Available

  • CHU Tours

    Tours,
    France

    Site Not Available

  • Hôpital Paul Brousse

    Villejuif,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.