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NCT Number: NCT06257407

Perioperative Hemostasis Management in Liver Transplantation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chru Minjoz, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: number of pRBCs transfused during surgery

    Number of intraoperative pRBCs transfused

Secondary outcomes

  1. Determine factors predicting transfusion of more than 2 pRBCs intraoperatively

    Time frame: During surgery

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

  2. Determine the predictive factors for intraoperative transfusion of RBCs for LT

    Time frame: During surgery

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

  3. Determine the predictive factors of the number of RBCs transfused at each phase of LT

    Time frame: During surgery

    (quantitative) number of pRBCs transfused during each of the 3 phases of LT

  4. Determine factors predicting intraoperative bleeding volume in LT

    Time frame: During surgery

    intraoperative bleeding volume

  5. Determine haemoglobin mass loss in patients not receiving intraoperative pRBC transfusion of LT

    Time frame: During surgery

    Haemoglobin mass loss

  6. Describe haemostatic tests (conventional biological and viscoelastic) carried out intraoperatively on LT. By listing all haemostatic tests performed

    Time frame: During surgery

    Haemostatic tests performed

  7. 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.

    Time frame: During surgery

    Blood products, blood-derived medicinal products, antifibrinolytics

  8. Determine the factors predicting the number of RBCs transfused within 24 hours post-LT

    Time frame: During 24 hours post-LT

    (quantitative) number of RBCs transfused in the 24 hours post-LT

  9. 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.

    Time frame: During operation

    Results of haemostatic tests performed after bleeding or transfusion

  10. Describe the post-operative use of anti-aggregants and anticoagulants drugs in LT

    Time frame: During the first 30 days postoperative LT

    Listing of Antiaggregation and thromboprophylaxis used

  11. Describe postoperative venous thrombotic events (deep vein thrombosis, pulmonary embolism, portal thrombosis) and arterial (graft artery thrombosis) during the first 30 days postoperative LT

    Time frame: During the first 30 days postoperative LT

    Thrombotic complications

  12. Measure the possible effect of the various pro- and antihaemostatic treatments on haemorrhagic and thrombotic complications in the first 30 days after LT surgery

    Time frame: During the first 30 days postoperative LT

    Thrombotic complications and haemorrhagic complications

  13. Explore the links between thombothic events and the results of hemostatic tests (common biological tests and viscoelastic tests)

    Time frame: thombotic events observed during the first 30 days postoperative LT

    Results of hemostatic tests performed during thrombothic events

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel WEISS, MD

CONTACT

[email protected]

+33 1 40 87 58 81

Stéphanie ROULLET, MD

CONTACT

[email protected]

+33 1 45 59 32 19

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Collaborators

  • Laboratoire français de Fractionnement et de Biotechnologies

Registry information

Acronym: HEMOTRANSPLANT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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