Liver CirrhosisPIMLivTNCT07111221
Portal Inflow Modulation Prior to Liver Transplantation in Patients With Increased Risk of Intraoperative Blood Loss
A study testing Transjugular Intrahepatic Portosystemic Shunt and Non-selective beta-blockers in people with Liver Cirrhosis and Clinically Significant Portal Hypertension, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Clinically Significant Portal Hypertension
- What is being tested?
- Transjugular Intrahepatic Portosystemic Shunt and Non-selective beta-blockers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 sitePoland
- Study dates
- 24 Jun 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Re-transplantation
- Previous surgery in the upper abdomen
- History of esophageal variceal bleeding
- History of spontaneous bacterial peritonitis
- Planned thrombectomy during liver transplantation
Who cannot join
- Heart failure (EF <50%)
- Severe right ventricular failure
- Severe pulmonary hypertension
- Systemic infection
- Portal vein thrombosis (Yerdel >1)
- Severe coagulopathy (INR >5)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zuzanna Łuczak contact
Poland1 site, 1 recruiting
- Recruiting
University Clinical Centre of the Medical University of Warsaw
Warsaw
Wacław Hołówko, dr hab. n. med., +48 667 667 044, waclaw.holowko@wum.edu.pl
About this study
Official 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.
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.
Read more
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.
- Being tested
- Transjugular Intrahepatic Portosystemic Shunt, Non-selective beta-blockers
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular Intrahepatic Portosystemic ShuntProcedure or surgery
Also called TIPS
Transjugular Intrahepatic Portosystemic Shunt performed prior to liver transplantation in patients with increased risk of intraoperative blood loss
Non-selective beta-blockersDrug
Also called NSBBs
Non-selective beta-blockers for lowering portal hypertension
| Study group | Role | What they receive |
|---|---|---|
| Non-selective beta blockers | Active comparator | Non-selective beta blockers for treatment of portal hypertension Receives: Drug: Non-selective beta-blockers |
| Non-selective beta blockers + TIPS | Experimental | Non-selective beta blockers and TIPS for treatment of portal hypertension Receives: Procedure: Transjugular Intrahepatic Portosystemic Shunt; Drug: Non-selective beta-blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of red blood cell units transfused during liver transplantation.
Measured: Intraoperative
Secondary outcomes (7)
Portal vein blood flow
Blood flow velocity in the portal vein during liver transplantation
Measured: Intraoperative
Intraoperative blood loss
Blood loss during liver transplantation [ml]
Measured: Intraoperative
Operation time
Time of surgery [min]
Measured: Intraoperative
Postoperative complications
CCI index and the percentage of complications ≥ grade 3 according to the Clavien-Dindo classification after liver transplantation
Measured: Up to 90 days
Time of hospitalisation
Postoperative hospitalisation [days]
Measured: Up to 90 days
Variceal bleeding
Esophageal variceal bleeding before transplantation
Measured: Preoperative
Overall survival
Survival from the time of qualification for liver transplantation and up to 90 days after liver transplantation
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start24 Jun 2025
- Primary completionOct 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111221
- Sponsor's protocol ID
- ABM32
- Acronym
- PIMLivT
- Status last verified
- Jun 2025
- First submitted
- 21 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07111221
- Acronym / sponsor ID
- PIMLivT / ABM32
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-selective beta blockers | Active comparator | Drug: Non-selective beta-blockersNon-selective beta blockers for treatment of portal hypertension |
| Non-selective beta blockers + TIPS | Experimental | Procedure: Transjugular Intrahepatic Portosystemic Shunt, Drug: Non-selective beta-blockersNon-selective beta blockers and TIPS for treatment of portal hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- Heart failure (EF <50%)
- Severe right ventricular failure
- Severe pulmonary hypertension
- Systemic infection
- Portal vein thrombosis (Yerdel >1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transjugular Intrahepatic Portosystemic ShuntAlso: TIPSTransjugular Intrahepatic Portosystemic Shunt performed prior to liver transplantation in patients with increased risk of intraoperative blood loss | Procedure or surgery | Non-selective beta blockers + TIPS |
| Non-selective beta-blockersAlso: NSBBsNon-selective beta-blockers for lowering portal hypertension | Drug | Non-selective beta blockers, Non-selective beta blockers + TIPS |
Primary outcome
Number of red blood cell units transfused during liver transplantation.
Time frame: Intraoperative
7 secondary outcomes
Portal vein blood flow
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
Operation time
Time frame: Intraoperative
Postoperative complications
Time frame: Up to 90 days
Time of hospitalisation
Time frame: Up to 90 days
Variceal bleeding
Time frame: Preoperative
Overall survival
Time frame: Up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuzanna Łuczak contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transjugular Intrahepatic Portosystemic Shunt and Non-selective beta-blockers in people with Liver Cirrhosis and Clinically Significant Portal Hypertension, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wacław Hołówko, dr hab. n. med. (+48 667 667 044, waclaw.holowko@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of red blood cell units transfused during liver transplantation. (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.