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

Instituto de Investigación Marqués de Valdecilla

Status

Enrolling

Conditions

Cirrhosis, Liver

Treatments

Device: Rotational thromboelastometry

Study type

Observational

Funder types

Other

Identifiers

NCT06908785

CIR-ROTEM

Details and patient eligibility

About

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 restrictive transfusion policy, adherence remains low, with a high rate of prophylactic transfusions despite unclear benefits. This multicenter, prospective, and observational study will evaluate the utility of ROTEM in bleeding risk stratification for cirrhotic patients with significant abnormalities in conventional hemostasis tests undergoing high-risk invasive procedures. The primary objective is to establish cut-off values with a high negative predictive value, optimizing transfusion decisions and reducing unnecessary blood product use. Additionally, the study will analyze the relationship between ROTEM, inflammation biomarkers, and coagulation factors, along with a cost-effectiveness analysis comparing different transfusion strategies. This will be the largest study to date assessing ROTEM in this setting, overcoming the limitations of previous studies, which have been mostly retrospective with heterogeneous populations and procedures. Its findings could contribute to the standardization of transfusion management in cirrhosis and improve healthcare resource efficiency. The widespread availability of ROTEM in other disciplines within the National Health System will facilitate its implementation in this clinical setting without requiring additional investment in equipment.

Enrollment

330 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.