Using ROTEM to assess bleeding risk in cirrhosis patients after procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: jose ignacio fortea
• Email: jifortea@gmail.com
• Phone: 942202520

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.