Perioperative Hemostasis Management in Liver Transplantation (HEMOTRANSPLANT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant; Complications

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Emmanuel WEISS, MD; Phone Number: +33 1 40 87 58 81; Email: emmanuel.weiss@aphp.fr
• Study Contact Backup: Name: Stéphanie ROULLET, MD; Phone Number: +33 1 45 59 32 19; Email: stephanie.roullet@aphp.fr

Study Locations

• France
  • Besançon, France
    • Chru Minjoz
    • Contact: Cyrielle DESPRES, MD
  • Clermont, France
    • CHU Estaing
    • Contact: Renaud GUERIN, MD
  • Clichy, France
    • Hopital Beaujon
    • Contact: Pauline DEVAUCHELLE, MD
  • Grenoble, France
    • CHU Grenoble Alpes
    • Contact: Alexandre GODON, MD
  • Lille, France
    • CHU Claude Huriez
    • Contact: Anne BIGNON, MD
  • Lyon, France
    • Hopital de la Croix-Rousse
    • Contact: Pierre JACQUENOD Pierre, MD
  • Marseille, France
    • CHU La Timone
    • Contact: Benedicte GRIGORESCO, MD
  • Montpellier, France
    • Hôpital St Eloi
    • Contact: Clément MONET, MD
  • Nice, France
    • Hopital de l'archet 2
    • Contact: Romain ROZIER Romain, MD
  • Paris, France
    • CHU Pitié-Salpêtrière
    • Contact: Antoine MONSEL, MD
  • Pessac, France
    • CHU Haut Leveque
    • Contact: Elsa DELOGE, MD
  • Rennes, France
    • CHU Pontchaillou
    • Contact: Axelle MAURICE, MD
  • Strasbourg, France
    • CHU HautePierre
    • Contact: Paul BRUNET, MD
  • Toulouse, France
    • CHU Toulouse Rangueil
    • Contact: Vincent ETIENNE, MD
  • Tours, France
    • Chu Tours
    • Contact: Isaure BRETEAU, MD
  • Villejuif, France
    • Hopital Paul Brousse
    • Contact: Stephanie ROULLET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Liver transplant patient

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adults Patients with Liver transplant; No intervention during this observational study. Patient who meet the inclusion criteria will be included

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine factors predicting transfusion of more than 2 pRBCs intraoperatively	(qualitative binary) transfusion of more than 2 intraoperative RBCs (Y/N)	During surgery
Determine the predictive factors for intraoperative transfusion of RBCs for LT	(qualitative binary) intraoperative use of packed red blood cells (Y/N)	During surgery
Determine the predictive factors of the number of RBCs transfused at each phase of LT	(quantitative) number of pRBCs transfused during each of the 3 phases of LT	During surgery
Determine factors predicting intraoperative bleeding volume in LT	intraoperative bleeding volume	During surgery
Determine haemoglobin mass loss in patients not receiving intraoperative pRBC transfusion of LT	Haemoglobin mass loss	During surgery
Describe haemostatic tests (conventional biological and viscoelastic) carried out intraoperatively on LT. By listing all haemostatic tests performed	Haemostatic tests performed	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.	Blood products, blood-derived medicinal products, antifibrinolytics	During surgery
Determine the factors predicting the number of RBCs transfused within 24 hours post-LT	(quantitative) number of RBCs transfused in the 24 hours post-LT	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.	Results of haemostatic tests performed after bleeding or transfusion	During operation
Describe the post-operative use of anti-aggregants and anticoagulants drugs in LT	Listing of Antiaggregation and thromboprophylaxis used	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	Thrombotic complications	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	Thrombotic complications and haemorrhagic complications	During the first 30 days postoperative LT
Explore the links between thombothic events and the results of hemostatic tests (common biological tests and viscoelastic tests)	Results of hemostatic tests performed during thrombothic events	thombotic events observed during the first 30 days postoperative LT

Collaborators and Investigators

• Sponsor: Société Française d'Anesthésie et de Réanimation
• Collaborators: Laboratoire français de Fractionnement et de Biotechnologies
• Investigators: Principal Investigator: WEISS, MD, Hopital Beaujon

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HEMOTRANSPLANT / 2022-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No