Perioperative Hemostasis Management in Liver Transplantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociété Française d'Anesthésie et de Réanimation

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 or over

Liver transplant patient

Disqualifiers

Multi-organ transplantation

Protected populations: under guardianship or curatorship

Patients not affiliated to a social security scheme

Trial population

Liver transplant patient

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 1 trial group
Group A: Adults Patients with Liver transplant

Trial outcomes

Primary outcomes

1

Determine factors that predict the number of red blood cells packed (pRBCs) transfused intraoperatively in LT

Number of intraoperative pRBCs transfused

Time frame
number of pRBCs transfused during surgery

Secondary outcomes

1

Determine factors predicting transfusion of more than 2 pRBCs intraoperatively

(qualitative binary) transfusion of more than 2 intraoperative RBCs (Y/N)

Time frame
During surgery
2

Determine the predictive factors for intraoperative transfusion of RBCs for LT

(qualitative binary) intraoperative use of packed red blood cells (Y/N)

Time frame
During surgery
3

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

Time frame
During surgery
4

Determine factors predicting intraoperative bleeding volume in LT

intraoperative bleeding volume

Time frame
During surgery

Other outcomes

Sponsors and contacts

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Société Française d'Anesthésie et de Réanimation

Lead sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Collaborator