University Clinical Centre of the Medical University of Warsaw
Warsaw, Poland
Location status: Recruiting
NCT Number: NCT07111221
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Warsaw, Poland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 for lowering portal hypertension
Other names: NSBBs
Time frame: Intraoperative
Time frame: Intraoperative
Blood flow velocity in the portal vein during liver transplantation
Time frame: Intraoperative
Blood loss during liver transplantation [ml]
Time frame: Intraoperative
Time of surgery [min]
Time frame: Up to 90 days
CCI index and the percentage of complications ≥ grade 3 according to the Clavien-Dindo classification after liver transplantation
Time frame: Up to 90 days
Postoperative hospitalisation [days]
Time frame: Preoperative
Esophageal variceal bleeding before transplantation
Time frame: Up to 90 days
Survival from the time of qualification for liver transplantation and up to 90 days after liver transplantation
Contact information is provided by the study sponsor or research team.
Wacław Hołówko, dr hab. n. med.
CONTACT
Zuzanna Łuczak
CONTACT
Medical University of Warsaw
Other
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
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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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