Perioperative Hemostasis Management in Liver Transplantation
HEMOTRANSPLANT
1 other identifier
observational
1,200
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedStudy Start
First participant enrolled
October 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 2, 2026
March 1, 2026
2 years
January 31, 2024
March 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT
Number of intraoperative pRBCs transfused
number of pRBCs transfused during surgery
Secondary Outcomes (13)
Determine factors predicting transfusion of more than 2 pRBCs intraoperatively
During surgery
Determine the predictive factors for intraoperative transfusion of RBCs for LT
During surgery
Determine the predictive factors of the number of RBCs transfused at each phase of LT
During surgery
Determine factors predicting intraoperative bleeding volume in LT
During surgery
Determine haemoglobin mass loss in patients not receiving intraoperative pRBC transfusion of LT
During surgery
- +8 more secondary outcomes
Study Arms (1)
Adults Patients with Liver transplant
No intervention during this observational study. Patient who meet the inclusion criteria will be included
Eligibility Criteria
Liver transplant patient
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Chru Minjoz
Besançon, France
CHU Estaing
Clermont, France
Hôpital Beaujon
Clichy, France
CHU Grenoble Alpes
Grenoble, France
CHU Claude Huriez
Lille, France
Hôpital de la Croix-Rousse
Lyon, 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 Toulouse Rangueil
Toulouse, France
CHU Tours
Tours, France
Hôpital Paul Brousse
Villejuif, France
Study Officials
- PRINCIPAL INVESTIGATOR
WEISS, MD
Hôpital Beaujon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2024
First Posted
February 14, 2024
Study Start
October 17, 2024
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 2, 2026
Record last verified: 2026-03