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Recruiting Observational

Perioperative Hemostasis Management in Liver Transplantation

NCT06257407 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-10-17
Last updated
2026-04-02

Condition(s) studied

Liver Transplant; Complications

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT — number of pRBCs transfused during surgery
    Number of intraoperative pRBCs transfused

Trial sites (16)

FacilityCityRegionStatus
Chru Minjoz Besançon France Recruiting
CHU Estaing Clermont France Not Yet Recruiting
Hôpital Beaujon Clichy France Not Yet Recruiting
CHU Grenoble Alpes Grenoble France Not Yet Recruiting
CHU Claude Huriez Lille France Recruiting
Hôpital de la Croix-Rousse Lyon France Recruiting
CHU La Timone Marseille France Not Yet Recruiting
Hôpital St Eloi Montpellier France Not Yet Recruiting
Hôpital De L'Archet 2 Nice France Not Yet Recruiting
CHU Pitié-Salpêtrière Paris France Not Yet Recruiting
CHU Haut Levêque Pessac France Not Yet Recruiting
CHU Pontchaillou Rennes France Not Yet Recruiting
CHU Hautepierre Strasbourg France Not Yet Recruiting
CHU Toulouse Rangueil Toulouse France Not Yet Recruiting
CHU Tours Tours France Not Yet Recruiting
Hôpital Paul Brousse Villejuif France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06257407 on ClinicalTrials.gov ↗ ← All trials in France