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

July 31, 2025 updated by: Medical University of Warsaw

A Prospective, Randomized Study Evaluating the Effectiveness of Portal Hypertension Modulation in the Preoperative Period in Patients at Increased Risk of Massive Blood Loss During Liver Transplantation.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • University Clinical Centre of the Medical University of Warsaw
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-selective beta blockers
Non-selective beta blockers for treatment of portal hypertension
Drug: Non-selective beta-blockers
Non-selective beta-blockers for lowering portal hypertension
Other Names:
  • NSBBs
Experimental: Non-selective beta blockers + TIPS
Non-selective beta blockers and TIPS for treatment of portal hypertension
Drug: Non-selective beta-blockers
Non-selective beta-blockers for lowering portal hypertension
Other Names:
  • NSBBs
Procedure: Transjugular Intrahepatic Portosystemic Shunt
Transjugular Intrahepatic Portosystemic Shunt performed prior to liver transplantation in patients with increased risk of intraoperative blood loss
Other Names:
  • TIPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of red blood cell units transfused during liver transplantation.
Time Frame: Intraoperative
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Portal vein blood flow
Time Frame: Intraoperative
Blood flow velocity in the portal vein during liver transplantation
Intraoperative
Intraoperative blood loss
Time Frame: Intraoperative
Blood loss during liver transplantation [ml]
Intraoperative
Operation time
Time Frame: Intraoperative
Time of surgery [min]
Intraoperative
Postoperative complications
Time Frame: Up to 90 days
CCI index and the percentage of complications ≥ grade 3 according to the Clavien-Dindo classification after liver transplantation
Up to 90 days
Time of hospitalisation
Time Frame: Up to 90 days
Postoperative hospitalisation [days]
Up to 90 days
Variceal bleeding
Time Frame: Preoperative
Esophageal variceal bleeding before transplantation
Preoperative
Overall survival
Time Frame: Up to 90 days
Survival from the time of qualification for liver transplantation and up to 90 days after liver transplantation
Up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Medical Research Agency, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

July 31, 2025

First Posted (Actual)

August 8, 2025

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABM32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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