Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07111221

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

Led by Medical University of Warsaw · Updated on 2025-08-08

104

Participants Needed

1

Research Sites

231 weeks

Total Duration

On this page

Sponsors

M

Medical University of Warsaw

Lead Sponsor

M

Medical Research Agency, Poland

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 cause of death while awaiting liver transplantation. According to the Baveno VII guidelines, if bleeding recurs despite the use of non-selective β-blockers, a transjugular intrahepatic portosystemic shunt (TIPS) should be considered. Significant reduction of portal pressure is observed in up to 50% of patients treated with propranolol and up to 75% with carvedilol. TIPS effectively prevents bleeding caused by portal hypertension. However, recommendations for pre-transplant management of portal hypertension do not address the reduction of blood loss risk during liver transplantation. Previous studies evaluating the use of TIPS before transplantation primarily confirmed its safety and showed no significant increase in intraoperative risk. One analysis even suggested using TIPS in all patients with portal hypertension awaiting liver transplantation. Although some studies have addressed the issue of blood loss during transplantation, they were observational and retrospective, without distinguishing patients at particularly high risk of massive blood loss. So far, the effectiveness of TIPS in reducing blood loss during liver transplantation has not been confirmed-nor have studies reliably excluded such potential. The objective of the study is to directly compare the effectiveness of two different methods of modulating portal hypertension in the context of the risk of massive blood loss during liver transplantation. We hypothesize that the superior effectiveness of TIPS in significantly reducing portal hypertension may lead to a significant decrease in blood loss and the need for transfusion of blood products in patients at high risk of massive blood loss.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Qualification for elective liver transplantation from a deceased donor
  • Age 18 years or older
  • Body mass index between 18.5 kg/m8 and 30 kg/m8
  • Given informed consent to participate in the study
  • Clinically significant portal hypertension
  • At least one risk factor for massive blood loss, including re-transplantation, previous upper abdominal surgery, history of esophageal variceal bleeding, history of spontaneous bacterial peritonitis, or planned thrombectomy during liver transplantation
Not Eligible

You will not qualify if you...

  • Heart failure with ejection fraction below 50%
  • Severe right ventricular failure
  • Severe pulmonary hypertension
  • Systemic infection
  • Portal vein thrombosis with Yerdel grade greater than 1
  • Severe coagulopathy with INR greater than 5
  • Platelet count below 20,000/ml
  • Severe or uncontrolled encephalopathy with ammonia concentration above 100 bcmol/l
  • Contraindications to TIPS procedure
  • Contraindications to non-selective beta-blocker therapy
  • Pregnancy
  • Lack of informed consent to participate in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Clinical Centre of the Medical University of Warsaw

Warsaw, Poland

Actively Recruiting

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Research Team

W

Wacław Hołówko, dr hab. n. med.

CONTACT

Z

Zuzanna Łuczak

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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