A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis

Last updated: June 22, 2025
Sponsor: Bayer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombocytopenia And Thrombocytopenia Prevention

Soft Tissue Infections

Treatment

Local standard medical care

Clinical Study ID

NCT06986798
22795
  • Ages > 18
  • All Genders

Study Summary

This is an exploratory study in which data from people with sepsis (a serious condition in which the body responds to an infection that damages vital organs) admitted to an Intensive care unit (ICU) who will receive treatment are studied.

Sepsis is a serious condition that happens when the body's reaction to an infection causes organ damage. Disseminated intravascular coagulation (DIC) is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. DIC is a serious condition that can happen in people with sepsis, which may further lead to organ damage or even death.

No investigational products will be administered in this study. Participants will be treated with the standard of care (SOC) for sepsis. The SOC is the treatment that medical experts consider most appropriate currently.

There are limited treatments available for DIC, especially for people with sepsis and other diseases. To better understand the impact of sepsis, and how it develops into DIC, more knowledge is needed in the European population.

The main purpose of this study is to learn about how sepsis worsens, especially from the time a person is admitted to the ICU until they develop DIC. To do this, researchers will identify certain biomarkers to understand how DIC develops and progresses in people with sepsis. A biomarker is present in blood, other body fluids, or tissues and indicates a disease or abnormal process inside the body.

To learn about this, researchers will collect information about the participants who develop DIC, including cause, and severity of DIC (using a score called ISTH DIC Score). The data will be collected from participants' hospital records in more than three European countries. Each participant will be in the study for up to 56 days. During the study, the doctors and their study team will take blood samples up to 6 times to check for the presence of biomarkers for the identification of people with DIC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be 18 years of age inclusive, at the time of signing the informedconsent.

  • Participants with diagnosed sepsis according to sepsis-3 definition.

  • Participants with documented suspected origin of infection.

  • Informed consent of capable participant or, in case of participant being incapableof giving informed consent, consent for study inclusion will be sought according toapplicable laws and regulations.

Exclusion

Exclusion Criteria:

  • Patients deferred from other Intensive Care Units (ICUs).

  • Patients longer than 24 hours on ICU.

  • Known coagulation disorder.

  • Ongoing active clinically significant bleeding.

  • Participants experienced trauma or major surgery (within 4 weeks).

  • Active malignancy.

  • Decompensated liver impairment Child-Pugh Class C.

  • Moribund patients not expected to survive 24 hours (clinical decision).

  • Ongoing therapeutic anticoagulation (prophylactic dose of Unfractionated Heparin [UFH]/Low Molecular Weight Heparin [LMWH] is allowed) or antiplatelet therapy (except low dose [≤100 mg] acetyl salicylic acid [ASA]). If previously namedtreatment can be stopped the participants will be eligible if a "wash out"-time offive half-lives is applied before start of study.

  • Patients who have received any investigational drug involving pharmacologicalinterventions, or biological or cell therapy interventions or prohibited therapywithin 28 days or five half-lives, whichever is longer, prior to screening/baseline.

  • Any reason that would make participation unadvisable, at the discretion of theinvestigator.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Local standard medical care
Phase:
Study Start date:
January 29, 2025
Estimated Completion Date:
April 07, 2026

Connect with a study center

  • MedUni Graz | Innere Medizin, ICU

    Graz, 8036
    Austria

    Site Not Available

  • MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • MedUni Wien | Univ. Klinik für Klinische Pharmakologie

    Vienna, 1090
    Austria

    Site Not Available

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman

    Liège, 4000
    Belgium

    Active - Recruiting

  • Clinique Saint-Pierre d'Ottignies - Intensive Care

    Ottignies-Louvain-La-Neuve, 1340
    Belgium

    Active - Recruiting

  • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

    Woluwe Saint Lambert, 1200
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare

    Angers, 49100
    France

    Active - Recruiting

  • Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare

    Garches, 92380
    France

    Active - Recruiting

  • Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente

    La Roche-Sur-Yon, 85000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente

    Limoges, 87042
    France

    Active - Recruiting

  • Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation

    Nantes, 44000
    France

    Active - Recruiting

  • Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation

    Strasbourg, 67091
    France

    Active - Recruiting

  • CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation

    Tours, 37044
    France

    Active - Recruiting

  • Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik

    Köln, Nordrhein-Westfalen 51109
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Essen | Klinik für Anaesthesiologie und Intensivmedizin

    Essen, 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Klinik für Anaesthesiologie und Operative Intensivmedizin

    Kiel, 24105
    Germany

    Site Not Available

  • RKH Klinikum Ludwigsburg

    Ludwigsburg, 71640
    Germany

    Site Not Available

  • Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)

    München, 81377
    Germany

    Site Not Available

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Anestesia e TI Polivalente

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Carlo - Anestesia e Rianimazione

    Milano, 20153
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica

    Roma, 00168
    Italy

    Active - Recruiting

  • Humanitas Mirasole S.p.A. - Anestesia e Terapie Intensive

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Medisch Spectrum Twente - Intensive Care

    Enschede, 7512 KZ
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum St. Radboud

    Nijmegen, 6500HB
    Netherlands

    Site Not Available

  • Maasstad

    Rotterdam, 3079 DZ
    Netherlands

    Active - Recruiting

  • Hospital Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital Universitario de Getafe

    Getafe, Madrid 28905
    Spain

    Active - Recruiting

  • Hospital Universitario de Getafe - UCI

    Getafe, Madrid 28905
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

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