Perioperative Hemostasis Management in Liver Transplantation

Liver Transplant; Complications Clinical Trial

— HEMOTRANSPLANT  

Official title:

Perioperative Hemostasis Management in Liver Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06257407
• Other study ID #: HEMOTRANSPLANT / 2022-12
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Société Française d'Anesthésie et de Réanimation
• Contact: Emmanuel WEISS, MD
• Phone: +33 1 40 87 58 81
• Email: emmanuel.weiss[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant; Complications

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Société Française d'Anesthésie et de Réanimation	Laboratoire français de Fractionnement et de Biotechnologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine factors predicting transfusion of more than 2 pRBCs intraoperatively	(qualitative binary) transfusion of more than 2 intraoperative RBCs (Y/N)	During surgery
Secondary	Determine the predictive factors for intraoperative transfusion of RBCs for LT	(qualitative binary) intraoperative use of packed red blood cells (Y/N)	During surgery
Secondary	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
Secondary	Determine factors predicting intraoperative bleeding volume in LT	intraoperative bleeding volume	During surgery
Secondary	Determine haemoglobin mass loss in patients not receiving intraoperative pRBC transfusion of LT	Haemoglobin mass loss	During surgery
Secondary	Describe haemostatic tests (conventional biological and viscoelastic) carried out intraoperatively on LT. By listing all haemostatic tests performed	Haemostatic tests performed	During surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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