Utility of ROTEM® for Risk Stratification of Post-Invasive Procedure Hemorrhage in Patients With Cirrhosis (CIR-ROTEM)
NCT ID: NCT06908785
Last Updated: 2025-04-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
330 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-03-01
Study Completion Date
2028-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Color Doppler US and TE as Predictors for Presence of Gastroesophageal Varices and Variceal Bleeding in Patients With LC
NCT05891184
Gastroesophageal Varices Hemorrhage
UNKNOWN
Carvedilol vs Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding
NCT02066649
Portal Hypertension Related to Cirrhosis
WITHDRAWN
PHASE3
Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy
NCT05331768
Esophageal and Gastric Varices
COMPLETED
NA
Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
NCT05500625
Gastric Varix
UNKNOWN
NA
Efficacy and Safety of Variceal Embolization Combined With Partial Splenic Artery Embolization for Variceal Bleeding in Cavernous Transformation of Portal Vein.
NCT07310316
Cavernous Transformation of Portal Vein
Gastroesophageal Varices Bleeding
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Cirrhosis, Liver
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EXPERIMENTAL GROUP
cirrhosis undergoing invasive procedures
Rotational thromboelastometry
Intervention Type
DEVICE
rotem
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rotational thromboelastometry
rotem
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto de Investigación Marqués de Valdecilla
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital universitario Marques de Valdecilla
Santander, Cantabria, Spain
Site Status
RECRUITING
Hospital General Universitario Dr. Balmis de Alicante
Alicante, , Spain
Site Status
RECRUITING
Hospital Clinic Barcelona
Barcelona, , Spain
Site Status
RECRUITING
. Hospital de la Santa Creu i Sant
Barcelona, , Spain
Site Status
RECRUITING
Hospital Universitario de Bellvitge
Barcelona, , Spain
Site Status
RECRUITING
Hospital Universitario de Cruces
Bilbao, , Spain
Site Status
RECRUITING
Hospital Universitario de Burgos
Burgos, , Spain
Site Status
RECRUITING
hospital Ramon y Cajal
Madrid, , Spain
Site Status
RECRUITING
Hospital La Paz
Madrid, , Spain
Site Status
RECRUITING
Huca
Oviedo, , Spain
Site Status
RECRUITING
Hospital General Universitario de Toledo
Toledo, , Spain
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Spain
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Cayetano Miralles
Role: primary
Role: backup
Anabel Blasi
Role: primary
Role: backup
Marta Garcia
Role: primary
Role: backup
Rosa María Gutiérrez Rico
Role: primary
Role: backup
Judith Gomez
Role: primary
Role: backup
Consuelo Froilan
Role: primary
Role: backup
Maria luisa gonzalez
Role: primary
Role: backup
Marta Romero Gutierrez
Role: primary
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Zanetto A, Rinder HM, Senzolo M, Simioni P, Garcia-Tsao G. Reduced Clot Stability by Thromboelastography as a Potential Indicator of Procedure-Related Bleeding in Decompensated Cirrhosis. Hepatol Commun. 2020 Dec 12;5(2):272-282. doi: 10.1002/hep4.1641. eCollection 2021 Feb.
Reference Type
BACKGROUND
European Association for the Study of the Liver. EASL Clinical Practice Guidelines on prevention and management of bleeding and thrombosis in patients with cirrhosis. J Hepatol. 2022 May;76(5):1151-1184. doi: 10.1016/j.jhep.2021.09.003. Epub 2022 Mar 15.
Reference Type
BACKGROUND
Northup PG, Garcia-Pagan JC, Garcia-Tsao G, Intagliata NM, Superina RA, Roberts LN, Lisman T, Valla DC. Vascular Liver Disorders, Portal Vein Thrombosis, and Procedural Bleeding in Patients With Liver Disease: 2020 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Jan;73(1):366-413. doi: 10.1002/hep.31646. Epub 2021 Jan 20. No abstract available.
Reference Type
BACKGROUND
Northup PG, Friedman LS, Kamath PS. AGA Clinical Practice Update on Surgical Risk Assessment and Perioperative Management in Cirrhosis: Expert Review. Clin Gastroenterol Hepatol. 2019 Mar;17(4):595-606. doi: 10.1016/j.cgh.2018.09.043. Epub 2018 Sep 28. No abstract available.
Reference Type
BACKGROUND
Intagliata NM, Rahimi RS, Higuera-de-la-Tijera F, Simonetto DA, Farias AQ, Mazo DF, Boike JR, Stine JG, Serper M, Pereira G, Mattos AZ, Marciano S, Davis JPE, Benitez C, Chadha R, Mendez-Sanchez N, deLemos AS, Mohanty A, Dirchwolf M, Fortune BE, Northup PG, Patrie JT, Caldwell SH. Procedural-Related Bleeding in Hospitalized Patients With Liver Disease (PROC-BLeeD): An International, Prospective, Multicenter Observational Study. Gastroenterology. 2023 Sep;165(3):717-732. doi: 10.1053/j.gastro.2023.05.046. Epub 2023 Jun 2.
Reference Type
BACKGROUND
Pfisterer N, Schwarz M, Jachs M, Putre F, Ritt L, Mandorfer M, Madl C, Trauner M, Reiberger T. Endoscopic band ligation is safe despite low platelet count and high INR. Hepatol Int. 2023 Oct;17(5):1205-1214. doi: 10.1007/s12072-023-10515-y. Epub 2023 Apr 6.
Reference Type
BACKGROUND
Ronca V, Barabino M, Santambrogio R, Opocher E, Hodson J, Bertolini E, Birocchi S, Piccolo G, Battezzati P, Cattaneo M, Podda GM. Impact of Platelet Count on Perioperative Bleeding in Patients With Cirrhosis Undergoing Surgical Treatments of Liver Cancer. Hepatol Commun. 2022 Feb;6(2):423-434. doi: 10.1002/hep4.1806. Epub 2021 Oct 30.
Reference Type
BACKGROUND
Basili S, Raparelli V, Napoleone L, Talerico G, Corazza GR, Perticone F, Sacerdoti D, Andriulli A, Licata A, Pietrangelo A, Picardi A, Raimondo G, Violi F; PRO-LIVER Collaborators. Platelet Count Does Not Predict Bleeding in Cirrhotic Patients: Results from the PRO-LIVER Study. Am J Gastroenterol. 2018 Mar;113(3):368-375. doi: 10.1038/ajg.2017.457. Epub 2017 Dec 19.
Reference Type
BACKGROUND
Napolitano G, Iacobellis A, Merla A, Niro G, Valvano MR, Terracciano F, Siena D, Caruso M, Ippolito A, Mannuccio PM, Andriulli A. Bleeding after invasive procedures is rare and unpredicted by platelet counts in cirrhotic patients with thrombocytopenia. Eur J Intern Med. 2017 Mar;38:79-82. doi: 10.1016/j.ejim.2016.11.007. Epub 2016 Dec 15.
Reference Type
BACKGROUND
Bosch J, Thabut D, Albillos A, Carbonell N, Spicak J, Massard J, D'Amico G, Lebrec D, de Franchis R, Fabricius S, Cai Y, Bendtsen F; International Study Group on rFVIIa in UGI Hemorrhage. Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial. Hepatology. 2008 May;47(5):1604-14. doi: 10.1002/hep.22216.
Reference Type
BACKGROUND
Giannini EG, Greco A, Marenco S, Andorno E, Valente U, Savarino V. Incidence of bleeding following invasive procedures in patients with thrombocytopenia and advanced liver disease. Clin Gastroenterol Hepatol. 2010 Oct;8(10):899-902; quiz e109. doi: 10.1016/j.cgh.2010.06.018. Epub 2010 Jun 30.
Reference Type
BACKGROUND
Montalva E, Rodriguez-Peralvarez M, Blasi A, Bonanad S, Gavin O, Hierro L, Llado L, Llop E, Pozo-Laderas JC, Colmenero J; on behalf of the Spanish Society of Liver Transplantation and the Spanish Society of Thrombosis and Haemostasis. Consensus Statement on Hemostatic Management, Anticoagulation, and Antiplatelet Therapy in Liver Transplantation. Transplantation. 2022 Jun 1;106(6):1123-1131. doi: 10.1097/TP.0000000000004014. Epub 2022 Jan 4.
Reference Type
BACKGROUND
Under the auspices of the Italian Association for the Study of Liver Diseases (AISF) and the Italian Society of Internal Medicine (SIMI). Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference. Dig Liver Dis. 2016 May;48(5):455-467. doi: 10.1016/j.dld.2016.02.008. Epub 2016 Feb 27.
Reference Type
BACKGROUND
Simonetto DA, Singal AK, Garcia-Tsao G, Caldwell SH, Ahn J, Kamath PS. ACG Clinical Guideline: Disorders of the Hepatic and Mesenteric Circulation. Am J Gastroenterol. 2020 Jan;115(1):18-40. doi: 10.14309/ajg.0000000000000486.
Reference Type
BACKGROUND
Patel IJ, Rahim S, Davidson JC, Hanks SE, Tam AL, Walker TG, Wilkins LR, Sarode R, Weinberg I. Society of Interventional Radiology Consensus Guidelines for the Periprocedural Management of Thrombotic and Bleeding Risk in Patients Undergoing Percutaneous Image-Guided Interventions-Part II: Recommendations: Endorsed by the Canadian Association for Interventional Radiology and the Cardiovascular and Interventional Radiological Society of Europe. J Vasc Interv Radiol. 2019 Aug;30(8):1168-1184.e1. doi: 10.1016/j.jvir.2019.04.017. Epub 2019 Jun 20. No abstract available.
Reference Type
BACKGROUND
Roberts LN, Lisman T, Stanworth S, Hernandez-Gea V, Magnusson M, Tripodi A, Thachil J. Periprocedural management of abnormal coagulation parameters and thrombocytopenia in patients with cirrhosis: Guidance from the SSC of the ISTH. J Thromb Haemost. 2022 Jan;20(1):39-47. doi: 10.1111/jth.15562. Epub 2021 Nov 8.
Reference Type
BACKGROUND
O'Shea RS, Davitkov P, Ko CW, Rajasekhar A, Su GL, Sultan S, Allen AM, Falck-Ytter Y. AGA Clinical Practice Guideline on the Management of Coagulation Disorders in Patients With Cirrhosis. Gastroenterology. 2021 Nov;161(5):1615-1627.e1. doi: 10.1053/j.gastro.2021.08.015. Epub 2021 Sep 25. No abstract available.
Reference Type
BACKGROUND
Riescher-Tuczkiewicz A, Caldwell SH, Kamath PS, Villa E, Rautou PE; Bleeding in liver diseases investigatorsdagger; Bleeding in liver diseases investigators. Expert opinion on bleeding risk from invasive procedures in cirrhosis. JHEP Rep. 2023 Dec 19;6(3):100986. doi: 10.1016/j.jhepr.2023.100986. eCollection 2024 Mar.
Reference Type
BACKGROUND
Desborough MJ, Hockley B, Sekhar M, Burroughs AK, Stanworth SJ, Jairath V; National Audit Collaborative. Patterns of blood component use in cirrhosis: a nationwide study. Liver Int. 2016 Apr;36(4):522-9. doi: 10.1111/liv.12999. Epub 2015 Nov 26.
Reference Type
BACKGROUND
Lu Y, Sun G, Liu X, Liu Z, Tan J, Hao Y, Shan G, Luo Q, Wang D, Xing Y, Zhang X, Gong J, Stanworth SJ, Wang J, Wen A. Plasma Transfusion in Patients With Cirrhosis in China: A Retrospective Multicenter Cohort Study. Transfus Med Rev. 2017 Apr;31(2):107-112. doi: 10.1016/j.tmrv.2016.11.006. Epub 2016 Dec 2.
Reference Type
BACKGROUND
Fortea JI, Puente A, Ezcurra I, Cuadrado A, Arias-Loste MT, Cabezas J, Llerena S, Iruzubieta P, Rodriguez-Lope C, Huelin P, Casafont F, Fabrega E, Crespo J. Management of haemostatic alterations and associated disorders in cirrhosis in Spain: A national survey. Dig Liver Dis. 2019 Jan;51(1):95-103. doi: 10.1016/j.dld.2018.06.003. Epub 2018 Jun 12.
Reference Type
BACKGROUND
Tosetti G, Farina E, Caccia R, Sorge A, Berzuini A, Valenti L, Prati D, Tripodi A, Lampertico P, Primignani M. Preprocedural prophylaxis with blood products in patients with cirrhosis: Results from a survey of the Italian Association for the Study of the Liver (AISF). Dig Liver Dis. 2022 Nov;54(11):1520-1526. doi: 10.1016/j.dld.2022.03.017. Epub 2022 Apr 23.
Reference Type
BACKGROUND
Malleeswaran S, Sivajothi S, Reddy MS. Viscoelastic Monitoring in Liver Transplantation. Liver Transpl. 2022 Jun;28(6):1090-1102. doi: 10.1002/lt.26352. Epub 2021 Dec 3.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIR-ROTEM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices
NCT03624517
TERMINATED
PHASE4
Intraoperative Endovascular Treatment Via the Ligamentum Teres Hepatis in Liver Transplantation for Yerdel Grade Ⅲ/IV Portal Vein Thrombosis: A Safe and Effective Strategy
NCT07192653
COMPLETED
JETi Lower Extremity Venous Thrombosis
NCT07027878
ACTIVE_NOT_RECRUITING
Comparison of Treatments in Venous Insufficiency
NCT01298908
COMPLETED
NA
Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding
NCT00409084
TERMINATED
PHASE3
Primary Prevention of Gastric Varices Bleed
NCT05859009
WITHDRAWN
NA
Efficacy and Safety of Contrast EUS-Guided Tissue Glue/Coil Devascularization vs. BRTO for Preventing Recurrent Gastric Variceal Bleeding
NCT07049146
NOT_YET_RECRUITING
NA
JETi Lower Extremity Arterial Thrombosis
NCT04370691
COMPLETED
Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding
NCT06106971
UNKNOWN
PHASE3
Time Interval for Endoscopic Variceal Ligation
NCT01291277
COMPLETED
PHASE4
Tourniquet Study: A Clinical Trial Into the Effect of Tourniquet Use on the Coagulation System
NCT02567903
COMPLETED
NA
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
NCT05347550
RECRUITING
NA
Venous Thromboembolism (VTE) Knowledge
NCT05548010
COMPLETED
EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
NCT04075760
UNKNOWN
NA
EJV Occlusion Pressure Measurement to Assess Intravascular Volume in Cirrhotic Patients During IV Albumin Substitution
NCT06544161
COMPLETED
NA
Secondary Prophylaxis After Variceal Bleeding in Non-Responders
NCT00450164
COMPLETED
PHASE4
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery
NCT02397226
ACTIVE_NOT_RECRUITING
NA
Ultrasound Elasticity Imaging of Venous Thrombi
NCT00726947
COMPLETED
EARLY_PHASE1
Ultherapy for the Treatment of Spider Veins on the Legs
NCT02286804
COMPLETED
NA
"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices
NCT03705078
COMPLETED
NA
Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices
NCT05545475
UNKNOWN
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
NCT01335516
COMPLETED
Inferior Vena Cava Retrievable Filters: Spanish Register
NCT02757001
COMPLETED
Volume Estimation of the Limb After VEnous Treatment
NCT03703765
COMPLETED
NA
Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding Gastric Varices
NCT00820781
COMPLETED
NA