ROTEM-guided blood transfusions before high-bleeding-risk procedures in decompensated cirrhosis
Official title: Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing High Risk of Bleeding Invasive Procedures
Run by Grigore T. Popa University of Medicine and Pharmacy · NCT07437755 · Data updated 2026-11-12
This project will test whether using ROTEM to guide pre-procedure blood transfusions reduces unnecessary transfusions for people with decompensated liver cirrhosis undergoing high-bleeding-risk invasive procedures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | Grigore T. Popa University of Medicine and Pharmacy Academic / other |
| Locations | 1 site (Iași, Iaşi) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07437755 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with decompensated liver cirrhosis of any cause who are coagulopathic by conventional tests and are scheduled for a high-bleeding-risk invasive procedure and can give informed consent are the intended participants.
✕Probably not a fit
Patients with acute liver failure, current anticoagulant or antiplatelet use, recent blood product transfusions, advanced chronic kidney disease or sepsis are excluded and therefore unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional project compares two pre-procedural transfusion protocols in patients with decompensated liver cirrhosis: conventional coagulogram-guided care versus a thromboelastometry (ROTEM)-based algorithm. Eligible patients who are coagulopathic by standard tests and scheduled for high-bleeding-risk invasive procedures will be assigned to one of the two protocols prior to the procedure. The main outcome is expected to be the amount of blood components transfused before procedures, with safety endpoints including peri-procedural bleeding and transfusion-related complications. The investigators hypothesize that the ROTEM-guided approach will be safe and reduce the need for prophylactic blood product administration compared with standard care.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary pre-procedure blood transfusions and their associated risks for patients with decompensated cirrhosis.
How similar studies have gone: ROTEM-guided transfusion algorithms have shown benefit in surgical and trauma settings by better predicting bleeding and reducing transfusions, but evidence specifically in decompensated cirrhosis before invasive procedures remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Institute of Gastroenterology and Hepatology
Iași, Iaşi, Romania Recruiting
Study contacts
- Principal investigator: Irina Girleanu, Associated Professor — Grigore T. Popa University of Medicine and Pharmacy
- Study coordinator: Irina Girleanu, Associated Professor
- Email: gilda_iri25@yahoo.com
- Phone: +40762278575
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.