Informations générales (source: ClinicalTrials.gov)

NCT06257407 En recrutement IDF
Perioperative Hemostasis Management in Liver Transplantation (HEMOTRANSPLANT)
Observational
Société Française d'Anesthésie et de Réanimation (Voir sur ClinicalTrials)
octobre 2024
mars 2026
05 novembre 2024
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.

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Beaujon Pauline DEVAUCHELLE, MD Recrutement non commencé Contact (sur clinicalTrials)
AP-HP - Hôpital Paul Brousse Stephanie ROULLET, MD En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Chru Minjoz - Besançon - France Cyrielle DESPRES, MD En recrutement Contact (sur clinicalTrials)
CHU Claude Huriez - Lille - France Anne BIGNON, MD En recrutement Contact (sur clinicalTrials)
CHU Estaing - Clermont - France Renaud GUERIN, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Grenoble Alpes - Grenoble - France Alexandre GODON, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Haut Levêque - Pessac - France Elsa DELOGE, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Hautepierre - Strasbourg - France Paul BRUNET, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU La Timone - Marseille - France Benedicte GRIGORESCO, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Pitié-Salpêtrière - Paris - France Antoine MONSEL, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Pontchaillou - Rennes - France Axelle MAURICE, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Toulouse Rangueil - Toulouse - France Vincent ETIENNE, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Tours - Tours - France Isaure BRETEAU, MD Recrutement non commencé Contact (sur clinicalTrials)
Hôpital de la Croix-Rousse - Lyon - France Pierre JACQUENOD Pierre, MD En recrutement Contact (sur clinicalTrials)
Hôpital De L'Archet 2 - Nice - France Romain ROZIER Romain, MD Recrutement non commencé Contact (sur clinicalTrials)
Hôpital St Eloi - Montpellier - France Clément MONET, MD Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Patients aged 18 or over

- Liver transplant patient



- Multi-organ transplantation

- Protected populations: under guardianship or curatorship

- Patients not affiliated to a social security scheme