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NCT Number: NCT07111221

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Centre of the Medical University of Warsaw

Warsaw, Poland

Location status: Recruiting

Location contact

Wacław Hołówko, dr hab. n. med.

CONTACT

[email protected]

+48 667 667 044

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transjugular intrahepatic portosystemic shunt

Procedure

Transjugular Intrahepatic Portosystemic Shunt performed prior to liver transplantation in patients with increased risk of intraoperative blood loss

Other names: TIPS

Non-selective beta-blockers

Drug

Non-selective beta-blockers for lowering portal hypertension

Other names: NSBBs

Primary outcomes

  1. Number of red blood cell units transfused during liver transplantation.

    Time frame: Intraoperative

Secondary outcomes

  1. Portal vein blood flow

    Time frame: Intraoperative

    Blood flow velocity in the portal vein during liver transplantation

  2. Intraoperative blood loss

    Time frame: Intraoperative

    Blood loss during liver transplantation [ml]

  3. Operation time

    Time frame: Intraoperative

    Time of surgery [min]

  4. 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

  5. Time of hospitalisation

    Time frame: Up to 90 days

    Postoperative hospitalisation [days]

  6. Variceal bleeding

    Time frame: Preoperative

    Esophageal variceal bleeding before transplantation

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Wacław Hołówko, dr hab. n. med.

CONTACT

[email protected]

+48 667 667 044

Zuzanna Łuczak

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Medical Research Agency, Poland

Registry information

Official study title

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.

Acronym: PIMLivT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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