Using ROTEM to assess bleeding risk in cirrhosis patients after procedures

Utility of ROTEM® for Risk Stratification of Post-Invasive Procedure Hemorrhage in Patients With Cirrhosis (CIR-ROTEM)

This study is testing if a special blood test called ROTEM can help doctors predict bleeding risks in patients with cirrhosis who are having high-risk procedures.

Quick facts

• Study type: Observational
• Enrollment: 330 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Instituto de Investigación Marqués de Valdecilla (Academic / other)
• Locations: 11 sites (Santander, Cantabria and 10 other locations)
• Trial ID: NCT06908785 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of ROTEM, a viscoelastic test, in predicting the risk of post-procedural bleeding in patients with cirrhosis undergoing high-risk invasive procedures. By establishing cut-off values with high negative predictive value, the study aims to optimize transfusion decisions and minimize unnecessary blood product use. Additionally, it will analyze the relationship between ROTEM results, inflammation biomarkers, and coagulation factors, while also conducting a cost-effectiveness analysis of different transfusion strategies. This multicenter study is expected to provide valuable insights into managing bleeding risks in cirrhotic patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with diagnosed hepatic cirrhosis who are scheduled for high-risk invasive procedures.

Not a fit: Patients with acute-on-chronic liver failure, chronic kidney disease stage ≥3, or those with a history of thromboembolic complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk stratification and management of bleeding in cirrhotic patients, potentially reducing mortality and unnecessary transfusions.

How similar studies have performed: Previous studies have shown promise in using viscoelastic tests for bleeding risk assessment, but this approach in cirrhotic patients is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age between 18 and 85 years.
* Clinical, analytical, elastographic, histological, and/or imaging criteria consistent with the diagnosis of hepatic cirrhosis.
* Undergoing a high-risk invasive procedure, either in an outpatient setting or during hospitalization.
* Platelet count below 50,000/μL or INR greater than 1.5 with a platelet count below 100,000/μL.
* Signature of informed consent.

Exclusion Criteria:

* Cirrhotic patients with acute-on-chronic liver failure (ACLF) as defined by EASL criteria, and patients admitted to Intensive Care Units. These patients are excluded because hemostatic alterations in ACLF and critically ill patients are different and more pronounced compared to those in outpatient or general medical ward settings.
* Chronic kidney disease stage ≥3.
* Presence and/or history of thromboembolic complications.
* Presence of non-hepatic tumors.
* Presence of any primary hematologic disease (including inherited coagulopathies or thrombophilia).
* Recent surgery (\<8 weeks).
* History of organ transplantation, including liver transplantation.
* Pregnancy.
* Use of anticoagulants, antiplatelet agents other than acetylsalicylic acid, and/or antifibrinolytic therapy.
* Active disseminated intravascular coagulation.

Where this trial is running

Santander, Cantabria and 10 other locations

• Hospital universitario Marques de Valdecilla — Santander, Cantabria, Spain (Recruiting)
• Hospital General Universitario Dr. Balmis de Alicante — Alicante, Spain (Recruiting)
• Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
• . Hospital de la Santa Creu i Sant — Barcelona, Spain (Recruiting)
• Hospital Universitario de Bellvitge — Barcelona, Spain (Recruiting)
• Hospital Universitario de Cruces — Bilbao, Spain (Recruiting)
• Hospital Universitario de Burgos — Burgos, Spain (Recruiting)
• hospital Ramon y Cajal — Madrid, Spain (Recruiting)
• Hospital La Paz — Madrid, Spain (Recruiting)
• Huca — Oviedo, Spain (Recruiting)
• Hospital General Universitario de Toledo — Toledo, Spain (Recruiting)

Study contacts

• Study coordinator: jose ignacio fortea

Conditions Cirrhosis, Liver; Hemorrhage; Viscoelastic tests; Rotational thromboelastometry