RecruitingNCT06257407

Perioperative Hemostasis Management in Liver Transplantation


Sponsor

Société Française d'Anesthésie et de Réanimation

Enrollment

1,200 participants

Start Date

Oct 17, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Patients aged 18 or over
  • Liver transplant patient

Exclusion Criteria3

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

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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

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NCT06257407


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