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

April 2, 2025 updated by: Instituto de Investigación Marqués de Valdecilla
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario Dr. Balmis de Alicante
        • Contact:
          • Cayetano Miralles
        • Contact:
      • Barcelona, Spain, 08907
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic Barcelona
        • Contact:
          • Anabel Blasi
        • Contact:
      • Barcelona, Spain, 08041
      • Bilbao, Spain, 48903
        • Recruiting
        • Hospital Universitario de Cruces
        • Contact:
          • Rosa María Gutiérrez Rico
        • Contact:
      • Burgos, Spain
      • Madrid, Spain, 28034
      • Madrid, Spain
      • Oviedo, Spain
      • Toledo, Spain, 45007
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with cirrhosis undergoing invasive procedures

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EXPERIMENTAL GROUP
cirrhosis undergoing invasive procedures
Device: Rotational thromboelastometry
rotem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-procedural bleeding events within 28 days
Time Frame: 28 days after the procedure
Number of participants with bleeding events occurring within 28 days after undergoing a high-risk invasive procedure. Bleeding will be classified according to the International Society on Thrombosis and Haemostasis (ISTH) criteria. ROTEM parameters (Clotting Time [CT], Clot Formation Time [CFT], Amplitude at 5/10 minutes [A5, A10], Maximum Clot Firmness [MCF], Maximum Lysis [ML], and Lysis Index at 30 minutes [LI30]) will be measured pre-procedure and analyzed to determine cut-off values with high negative predictive value for post-procedural bleeding.
28 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Marqués de Valdecilla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIR-ROTEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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