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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital General Universitario Dr. Balmis de Alicante
RECRUITING
Alicante
. Hospital de la Santa Creu i Sant
RECRUITING
Barcelona
Hospital Clinic Barcelona
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
Barcelona
Hospital Universitario de Cruces
RECRUITING
Bilbao
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital La Paz
RECRUITING
Madrid
hospital Ramon y Cajal
RECRUITING
Madrid
Huca
RECRUITING
Oviedo
Hospital universitario Marques de Valdecilla
RECRUITING
Santander
Hospital General Universitario de Toledo
RECRUITING
Toledo
Contact Information
Primary
jose ignacio fortea
jifortea@gmail.com
942202520
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 330
Treatments
EXPERIMENTAL GROUP
cirrhosis undergoing invasive procedures
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigación Marqués de Valdecilla

This content was sourced from clinicaltrials.gov