Perioperative Hemostasis Management in Liver Transplantation
Recruiting now
Conditions studied: Liver Transplant; Complications
In brief
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 facts
- Study ID
- NCT06257407
- Run by
- Société Française d'Anesthésie et de Réanimation
- People needed
- 1200
- Starts
- 2024-10-17
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged 18 or over
- Liver transplant patient
You may not qualify if…
- Multi-organ transplantation
- Protected populations: under guardianship or curatorship
- Patients not affiliated to a social security scheme
Where it is running
- Chru Minjoz — Besançon, France (enrolling)
- CHU Claude Huriez — Lille, France (enrolling)
- Hôpital de la Croix-Rousse — Lyon, France (enrolling)
- Hôpital Paul Brousse — Villejuif, France (enrolling)
- CHU Toulouse Rangueil — Toulouse, France
- CHU Tours — Tours, 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 Estaing — Clermont, France
- Hôpital Beaujon — Clichy, France
- CHU Grenoble Alpes — Grenoble, France
Full record on ClinicalTrials.gov
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