Clinical trial NCT06257407: Perioperative Hemostasis Management in Liver Transplantation
Official title: Perioperative Hemostasis Management in Liver Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplant; Complications
Lead sponsor: Société Française d'Anesthésie et de Réanimation
Sponsor class: OTHER
Collaborators: name: Laboratoire français de Fractionnement et de Biotechnologies
First posted: 2024-02-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Liver transplant patient

Brief 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 criteria: 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 outcomes:
measure: Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT
timeFrame: number of pRBCs transfused during surgery
Secondary outcomes:
measure: Determine factors predicting transfusion of more than 2 pRBCs intraoperatively
timeFrame: During surgery
measure: Determine the predictive factors for intraoperative transfusion of RBCs for LT
timeFrame: During surgery
measure: Determine the predictive factors of the number of RBCs transfused at each phase of LT
timeFrame: During surgery
measure: Determine factors predicting intraoperative bleeding volume in LT
timeFrame: During surgery
measure: Determine haemoglobin mass loss in patients not receiving intraoperative pRBC transfusion of LT
timeFrame: During surgery
measure: Describe haemostatic tests (conventional biological and viscoelastic) carried out intraoperatively on LT. By listing all haemostatic tests performed
timeFrame: During surgery
measure: 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.
timeFrame: During surgery
measure: Determine the factors predicting the number of RBCs transfused within 24 hours post-LT
timeFrame: During 24 hours post-LT
measure: 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.
timeFrame: During operation
measure: Describe the post-operative use of anti-aggregants and anticoagulants drugs in LT
timeFrame: During the first 30 days postoperative LT
measure: Describe postoperative venous thrombotic events (deep vein thrombosis, pulmonary embolism, portal thrombosis) and arterial (graft artery thrombosis) during the first 30 days postoperative LT
timeFrame: During the first 30 days postoperative LT
measure: Measure the possible effect of the various pro- and antihaemostatic treatments on haemorrhagic and thrombotic complications in the first 30 days after LT surgery
timeFrame: During the first 30 days postoperative LT
measure: Explore the links between thombothic events and the results of hemostatic tests (common biological tests and viscoelastic tests)
timeFrame: thombotic events observed during the first 30 days postoperative LT
Other outcomes:
Locations:
city: Besançon
country: France
facility: Chru Minjoz
city: Clermont
country: France
facility: CHU Estaing
city: Clichy
country: France
facility: Hôpital Beaujon
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: CHU Claude Huriez
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Marseille
country: France
facility: CHU La Timone
city: Montpellier
country: France
facility: Hôpital St Eloi
city: Nice
country: France
facility: Hôpital De L'Archet 2
city: Paris
country: France
facility: CHU Pitié-Salpêtrière
city: Pessac
country: France
facility: CHU Haut Levêque
city: Rennes
country: France
facility: CHU Pontchaillou
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Tours
country: France
facility: CHU Tours
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
affiliation: Hôpital Beaujon
name: WEISS, MD
role: PRINCIPAL_INVESTIGATOR
References: