Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures
Recruiting now · Not applicable
Conditions studied: Liver Cirrhosis With Acute Decompensation
In brief
Patients with liver cirrhosis have historically received prophylactic transfusions before invasive procedures with high risk of bleeding. The optimal method for establishing the need of blood transfusion before invasive procedures in cirrhotic patients has not been determined yet, and there are not enough scientific data to warrant empirical transfusion. In many surgical and trauma-related contexts, viscoelastic tests, like Rotational Thromboelastometry (ROTEM), offer a comprehensive assessment of hemostasis, and it has been demonstrated to predict bleeding risk more accurately than traditional coagulation tests. The aim of this project is to evaluate the efficacy of a ROTEM-based algorithm in managing the administration of prophylactic blood components to patients diagnosed with decompensated liver cirrhosis undergoing invasive high risk of bleeding procedures. The investigators hypothesized that ROTEM-based decision-making will lead to a reduction in pre-procedural blood component usage, particularly fresh frozen plasma (FFP), compared with standard of care, whilst maintaining optimal clinical outcomes. The investigators will perform a prospective, single-center, randomized controlled clinical trial in a tertiary university hospital in Romania, comparing ROTEM-guided prophylactic blood component administration to standard of care in patients with decompensated cirrhosis and coagulopathy undergoing invasive procedures. Inclusion criteria: adults (aged 18 years or older) admitted with cirrhosis and an indication for high risk of bleeding invasive procedure defined as: transjugular liver biopsy, transjugular intrahepatic portosystemic shunt, endoscopic retrograde cholangio-pancreatography with sphincterotomy, endoscopic polypectomy of polyps more than 1 cm, variceal banding and complex dental extraction. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of blood products transfusion, hospital length of stay, in-hospital and 28-day mortality, incidence of minor bleeding, transfusion related adverse reactions, and cost analysis.
Key facts
- Study ID
- NCT07437755
- Run by
- Grigore T. Popa University of Medicine and Pharmacy
- People needed
- 116
- Starts
- 2025-06-01
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosed with decompensated liver cirrhosis of any etiology
- planned for a high risk of bleeding invasive procedure
- coagulopathic based on conventional coagulation tests and considered for pre-procedural blood component prophylaxis
- able and willing to provide informed consent
You may not qualify if…
- acute liver failure
- current use of anticoagulant treatment
- patients on antiplatelet aggregation agents
- patients who have received FFP, platelet transfusion, cryoprecipitate in the week prior to the procedure
- patients with stage 4 or 5 chronic kidney disease or patients receiving renal replacement therapy
- sepsis
Where it is running
- Institute of Gastroenterology and Hepatology — Iași, Iaşi, Romania (enrolling)
Full record on ClinicalTrials.gov
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