Status:
RECRUITING
Utility of ROTEM® for Risk Stratification of Post-Invasive Procedure Hemorrhage in Patients With Cirrhosis (CIR-ROTEM)
Lead Sponsor:
Instituto de Investigación Marqués de Valdecilla
Conditions:
Cirrhosis, Liver
Eligibility:
All Genders
18-65 years
Brief Summary
The assessment of post-procedural bleeding risk in cirrhosis remains a clinical challenge due to the lack of precise predictive tools and its high associated mortality. Although guidelines recommend a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT06908785
Start Date
March 1 2025
End Date
September 1 2028
Last Update
April 3 2025
Active Locations (11)
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1
Hospital universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
2
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Spain
3
Hospital Clinic Barcelona
Barcelona, Spain, 08036
4
. Hospital de la Santa Creu i Sant
Barcelona, Spain, 08041