Magnetic Resonance Cholangiopancreatography in Living Liver Donors and Its Relationship With Post Operative Recipient Biliary Complications
NCT07715500
Chronic Liver Disease and Cirrhosis, Donor Hepatectomy
New Delhi, India
View Trial DetailsNCT Number: NCT06257407
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Chru Minjoz, Besançon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: number of pRBCs transfused during surgery
Number of intraoperative pRBCs transfused
Time frame: During surgery
(qualitative binary) transfusion of more than 2 intraoperative RBCs (Y/N)
Time frame: During surgery
(qualitative binary) intraoperative use of packed red blood cells (Y/N)
Time frame: During surgery
(quantitative) number of pRBCs transfused during each of the 3 phases of LT
Time frame: During surgery
intraoperative bleeding volume
Time frame: During surgery
Haemoglobin mass loss
Time frame: During surgery
Haemostatic tests performed
Time frame: During surgery
Blood products, blood-derived medicinal products, antifibrinolytics
Time frame: During 24 hours post-LT
(quantitative) number of RBCs transfused in the 24 hours post-LT
Time frame: During operation
Results of haemostatic tests performed after bleeding or transfusion
Time frame: During the first 30 days postoperative LT
Listing of Antiaggregation and thromboprophylaxis used
Time frame: During the first 30 days postoperative LT
Thrombotic complications
Time frame: During the first 30 days postoperative LT
Thrombotic complications and haemorrhagic complications
Time frame: thombotic events observed during the first 30 days postoperative LT
Results of hemostatic tests performed during thrombothic events
Contact information is provided by the study sponsor or research team.
Emmanuel WEISS, MD
CONTACT
Stéphanie ROULLET, MD
CONTACT
Société Française d'Anesthésie et de Réanimation
Other
Acronym: HEMOTRANSPLANT
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