Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06257407

Perioperative Hemostasis Management in Liver Transplantation

Sponsor: Société Française d'Anesthésie et de Réanimation

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1200

Start Date

2024-10-17

Completion Date

2026-12-31

Last Updated

2026-04-02

Healthy Volunteers

No

Locations (16)

Chru Minjoz

Besançon, France

CHU Estaing

Clermont, France

Hôpital Beaujon

Clichy, France

CHU Grenoble Alpes

Grenoble, France

CHU Claude Huriez

Lille, France

Hôpital de la Croix-Rousse

Lyon, France

CHU La Timone

Marseille, France

Hôpital St Eloi

Montpellier, France

Hôpital De L'Archet 2

Nice, France

CHU Pitié-Salpêtrière

Paris, France

CHU Haut Levêque

Pessac, France

CHU Pontchaillou

Rennes, France

CHU Hautepierre

Strasbourg, France

CHU Toulouse Rangueil

Toulouse, France

CHU Tours

Tours, France

Hôpital Paul Brousse

Villejuif, France