Perioperative Hemostasis Management in Liver Transplantation

Обзор

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.

Первичные конечные точки

• Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT [Срок оценки: number of pRBCs transfused during surgery]

Вторичные конечные точки (12)

• Determine factors predicting transfusion of more than 2 pRBCs intraoperatively [Срок оценки: During surgery]
• Determine the predictive factors for intraoperative transfusion of RBCs for LT [Срок оценки: During surgery]
• Determine the predictive factors of the number of RBCs transfused at each phase of LT [Срок оценки: During surgery]
• Determine factors predicting intraoperative bleeding volume in LT [Срок оценки: During surgery]
• Determine haemoglobin mass loss in patients not receiving intraoperative pRBC transfusion of LT [Срок оценки: During surgery]
• Describe haemostatic tests (conventional biological and viscoelastic) carried out intraoperatively on LT. By listing all haemostatic tests performed [Срок оценки: During surgery]
• Describe the use of blood products, blood-derived medicinal products and antifibrinolytics administered during each phase of LT and during the first 24 hours postoperatively. By listing all products administered. [Срок оценки: During surgery]
• Determine the factors predicting the number of RBCs transfused within 24 hours post-LT [Срок оценки: During 24 hours post-LT]
• To explore the links between bleeding or transfusion and the results of haemostatic tests (conventional biological and viscoelastic) in peri-operative LT. By comparing occurance of bleeding or transfusion and values of haemostatic tests. [Срок оценки: During operation]
• Describe the post-operative use of anti-aggregants and anticoagulants drugs in LT [Срок оценки: During the first 30 days postoperative LT]
• Describe postoperative venous thrombotic events (deep vein thrombosis, pulmonary embolism, portal thrombosis) and arterial (graft artery thrombosis) during the first 30 days postoperative LT [Срок оценки: During the first 30 days postoperative LT]
• Measure the possible effect of the various pro- and antihaemostatic treatments on haemorrhagic and thrombotic complications in the first 30 days after LT surgery [Срок оценки: During the first 30 days postoperative LT]

Критерии участия

Критерии включения

• Patients aged 18 or over
• Liver transplant patient

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 16 центров

• Chru Minjoz — Besançon
• CHU Estaing — Clermont
• Hôpital Beaujon — Clichy
• CHU Grenoble Alpes — Grenoble
• CHU Claude Huriez — Lille
• Hôpital de la Croix-Rousse — Lyon
• CHU La Timone — Marseille
• Hôpital St Eloi — Montpellier
• … и ещё 8 центров

Идентификаторы

NCT: NCT06257407 · HEMOTRANSPLANT / 2022-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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