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Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures

RecruitingNAAges 18 Years - anyAllGrigore T. Popa University of Medicine and Pharma…
NCT07437755 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 hypothe

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Blood Products transfusion
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Where

1 site
Institute of Gastroenterology and Hepatology
Iași, Romania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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