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Portal Inflow Modulation Prior to Liver Transplantation in Patients With Increased Risk of Intraoperative Blood Loss

RecruitingNAAges 18 Years - anyAllMedical University of Warsaw
NCT07111221 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Liver transplantation is a procedure associated with an exceptionally high risk of blood loss. Liver failure, which is the most common indication for transplantation, not only leads to coagulation disorders but also to the development of portal hypertension. As a result, collateral circulation forms within the abdominal venous system, significantly increasing the risk of massive intraoperative blood loss. The number of intraoperatively transfused units of red blood cell concentrate is one of the main predictors of serious complications and postoperative mortality. Patients with portal hypertension awaiting liver transplantation should be treated with non-selective β-blockers, which reduce pressure in the portal system. This is primarily justified by the need to prevent esophageal variceal bleeding, one of the most common causes of decompensation in chronic liver failure and a potential

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📋 Eligibility rules (as published)
Inclusion Criteria: * Qualification for elective liver transplantation from a deceased donor * Age ≥18 years * BMI between 18.5 kg/m² and 30 kg/m² * Informed consent to participate in the study * Clinically significant portal hypertension * At least 1 of the following risk factors for massive blood loss: * Re-transplantation * Previous surgery in the upper abdomen * History of esophageal variceal bleeding * History of spontaneous bacterial peritonitis * Planned thrombectomy during liver transplantation Exclusion Criteria: * Heart failure (EF \<50%) * Severe right ventricular failure * Severe pulmonary hypertension * Systemic infection * Portal vein thrombosis (Yerdel \>1) * Severe coagulopathy (INR \>5) * Thrombocytopenia \<20,000/ml * Severe or uncontrolled encephalopathy (ammonia concentration \>100 μmol/l) * Contraindication to TIPS * Contraindication to therapy with non-selective beta-blockers * Pregnancy * Lack of informed consent to participate in the study
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What it tests

  • Transjugular Intrahepatic Portosystemic Shunt
  • Non-selective beta-blockers
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Where

1 site
University Clinical Centre of the Medical University of Warsaw
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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