Lowering portal pressure before liver transplant to reduce bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol enrolls adults with cirrhosis and clinically significant portal hypertension who are listed for elective deceased-donor liver transplantation and have predefined risk factors for massive intraoperative blood loss. Participants receive pre-transplant portal inflow modulation using either a transjugular intrahepatic portosystemic shunt (TIPS) or optimized non-selective beta-blocker therapy. The team will track intraoperative transfused red blood cell units, operative bleeding, and postoperative complications as primary outcomes. The trial is conducted at the University Clinical Centre of the Medical University of Warsaw under the lead sponsor Medical University of Warsaw.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Wacław Hołówko, dr hab. n. med.
• Email: waclaw.holowko@wum.edu.pl
• Phone: +48 667 667 044

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.