Lowering portal pressure before liver transplant to reduce bleeding
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.
We will test if lowering portal pressure with a TIPS procedure or with non-selective beta-blocker medication before liver transplant can reduce blood loss for adults with cirrhosis and clinically significant portal hypertension who are at higher risk of heavy bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT07111221 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with liver cirrhosis and clinically significant portal hypertension who are eligible for elective deceased-donor liver transplantation, have BMI 18.5–30 kg/m², have given informed consent, and have at least one listed risk factor for massive bleeding (for example retransplantation, prior upper-abdominal surgery, prior variceal bleeding, spontaneous bacterial peritonitis, or planned thrombectomy).
Not a fit: Patients with contraindications such as heart failure with EF <50%, severe right ventricular failure, severe pulmonary hypertension, systemic infection, high-grade portal vein thrombosis, severe coagulopathy or thrombocytopenia, uncontrolled encephalopathy, contraindication to TIPS or non-selective beta-blockers, pregnancy, or those who do not consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower intraoperative blood loss and transfusion needs, potentially reducing perioperative complications and postoperative mortality.
How similar studies have performed: Previous work shows TIPS and non-selective beta-blockers lower portal pressure and reduce variceal bleeding, but direct randomized evidence that pre-transplant portal modulation reduces intraoperative transfusions is limited and largely from observational series.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Warsaw
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.