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Cirrhosis, LiverCIR-ROTEMNCT06908785

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

An observational study of Cirrhosis, Liver, run by Instituto de Investigación Marqués de Valdecilla at 11 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cirrhosis, Liver
What is being tested?
Rotational thromboelastometry
Type of treatment
Medical device
How many people
330 participants
Where
11 sitesSpain
Study dates
1 Mar 2025to 1 Sep 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with cirrhosis undergoing invasive procedures

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 10Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

jose ignacio fortea contact

942202520 ext. 75047

jifortea@gmail.com

11 sites in 1 country

Spain11 sites, 11 recruiting

  • Hospital General Universitario Dr. Balmis de Alicante

    Alicante

    Cayetano Miralles

    cayetano.miralles@gmail.com

    Recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Anabel Blasi

    acardena@clinic.cat

    Recruiting

  • . Hospital de la Santa Creu i Sant

    Barcelona, 08041

    Edilmar Alvarado, EAlvaradoT@santpau.cat

    Recruiting

  • Hospital Universitario de Bellvitge

    Barcelona, 08907

    Marta Garcia

    mgarciagui.apms.ics@gencat.cat

    Recruiting

  • Hospital Universitario de Cruces

    Bilbao, 48903

    Rosa María Gutiérrez Rico

    rogurico@gmail.com

    Recruiting

  • Hospital Universitario de Burgos

    Burgos

    Judith Gomez

    jgomezcam@saludcastillayleon.es

    Recruiting

  • hospital Ramon y Cajal

    Madrid, 28034

    Luis Téllez Villajos, luistevilla@gmail.com

    Recruiting

  • Hospital La Paz

    Madrid

    Consuelo Froilan

    c_froilantorres@yahoo.es

    Recruiting

  • Huca

    Oviedo

    Maria luisa gonzalez

    luisagondi@hotmail.com

    Recruiting

  • Hospital universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    jose ignacio Fortea Ormaechea, 942 202520 ext. 75047, jifortea@gmail.com

    Recruiting

  • Hospital General Universitario de Toledo

    Toledo, 45007

    Marta Romero Gutierrez

    m.romero.gutierrez@gmail.com

    Recruiting

Other trials in Spain

About this study

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.

Being tested
Rotational thromboelastometry
Keywords
Hemorrhage, Viscoelastic tests, Rotational thromboelastometry
Medical subject headings
Liver Cirrhosis, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotational thromboelastometryDevice

    rotem

Study groups in NCT06908785
Study groupRoleWhat they receive
EXPERIMENTAL GROUPcirrhosis undergoing invasive procedures
Receives: Device: Rotational thromboelastometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of post-procedural bleeding events within 28 days

    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.

    Measured: 28 days after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start1 Mar 2025
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06908785
Sponsor's protocol ID
CIR-ROTEM
Acronym
CIR-ROTEM
Status last verified
Apr 2025
First submitted
25 Mar 2025
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33553974

  • 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.

    PubMed 35300861

  • 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.

    PubMed 33219529

  • 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.

    PubMed 30273751

  • 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.

    PubMed 37271290

  • 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.

    PubMed 37024710

  • 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.

    PubMed 34716696

  • 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.

    PubMed 29257146

  • 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.

    PubMed 27989373

  • 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.

    PubMed 18393319

  • 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.

    PubMed 20601131

  • 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.

    PubMed 34999660

  • 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.

    PubMed 27012444

  • 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.

    PubMed 31895720

  • 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.

    PubMed 31229333

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis, Liver, run by Instituto de Investigación Marqués de Valdecilla at 11 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jose ignacio fortea (942202520 ext. 75047, jifortea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of post-procedural bleeding events within 28 days (time frame: 28 days after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06908785, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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