NCT06908785

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 330 (estimated)
• Sponsor: Instituto de Investigación Marqués de Valdecilla · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
DEVICE	Rotational thromboelastometry	rotem

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-02-01
• Completion: 2028-09-01
• First posted: 2025-04-03
• Last updated: 2025-04-03

Locations

11 sites across 1 country: Spain