NCT07437755 Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures
| NCT ID | NCT07437755 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grigore T. Popa University of Medicine and Pharmacy |
| Condition | Liver Cirrhosis With Acute Decompensation |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 116 participants in total. It began in 2025-06-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Irina Girleanu, Associated Professor
PRINCIPAL INVESTIGATOR
Grigore T. Popa University of Medicine and Pharmacy
Frequently Asked Questions
Who can join the NCT07437755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis With Acute Decompensation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07437755 currently recruiting?
Yes, NCT07437755 is actively recruiting participants. Contact the research team at gilda_iri25@yahoo.com for enrollment information.
Where is the NCT07437755 trial being conducted?
This trial is being conducted at Iași, Romania.
Who is sponsoring the NCT07437755 clinical trial?
NCT07437755 is sponsored by Grigore T. Popa University of Medicine and Pharmacy. The principal investigator is Irina Girleanu, Associated Professor at Grigore T. Popa University of Medicine and Pharmacy. The trial plans to enroll 116 participants.