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

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.

Recruiting

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Key information

Conditions

Cirrhosis, Liver Digestive System Diseases Fibrosis Hemorrhage Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital universitario Marques de Valdecilla, Santander, Cantabria, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rotational thromboelastometry

Device

rotem

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

jose ignacio fortea

CONTACT

[email protected]

942202520 ext. 75047

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Marqués de Valdecilla

Other

Registry information

Acronym: CIR-ROTEM

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Apr 3, 2025
Registry last updated: Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed