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Sepsis, Sepsis associated DIC

Bayer Identifier:

22795

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People with Sepsis and Further Worsening of Sepsis

Trial purpose

This is an observational 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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Participant must be 18 years of age inclusive, at the time of signing the informed consent.
    - 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 incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.
  • - 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 named treatment can be stopped the participants will be eligible if a "wash out"-time of five half-lives is applied before start of study.
    - Patients who have received any investigational drug involving pharmacological interventions, or biological or cell therapy interventions or prohibited therapy within 28 days or five half-lives, whichever is longer, prior to screening/baseline.
    - Any reason that would make participation unadvisable, at the discretion of the investigator.

Trial summary

Enrollment Goal
150
Trial Dates
January 2025 - April 2026
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Hospital Universitari Vall d'HebronBarcelona, 08035, Spain
Not yet recruiting
Hospital Virgen del RocioSevilla, 41013, Spain
Not yet recruiting
Hospital Universitario de GetafeGetafe, 28905, Spain
Recruiting
Hospital Clinico San CarlosMadrid, 28040, Spain
Recruiting
Hospital Central de AsturiasOviedo, 33011, Spain
Not yet recruiting
Clinique Saint-Pierre d'Ottignies - Intensive CareOttignies-Louvain-La-Neuve, 1340, Belgium
Recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart TilmanLiège, 4000, Belgium
Recruiting
AZ Groeninge - Campus KennedylaanKortrijk, 8500, Belgium
Not yet recruiting
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-LucWoluwe Saint Lambert, 1200, Belgium
Not yet recruiting
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Carlo - Anestesia e RianimazioneMilano, 20153, Italy
Recruiting
Humanitas Mirasole S.p.A. - Anestesia e Terapie IntensiveRozzano, 20089, Italy
Not yet recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Anestesia e TI PolivalenteBologna, 40138, Italy
Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Anestesia, Rianimazione, Terapia Intensiva e Tossicologia ClinicaRoma, 00168, Italy
Recruiting
MaasstadRotterdam, 3079 DZ, Netherlands
Not yet recruiting
Universitair Medisch Centrum St. RadboudNijmegen, 6500HB, Netherlands
Recruiting
Medisch Spectrum Twente - Intensive CareEnschede, 7512 KZ, Netherlands
Recruiting
MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und NotfallmedizinInnsbruck, 6020, Austria
Not yet recruiting
MedUni Graz | Innere Medizin, ICUGraz, 8036, Austria
Not yet recruiting
MedUni Wien | Univ. Klinik für Klinische PharmakologieVienna, 1090, Austria
Not yet recruiting
RKH Klinikum LudwigsburgLudwigsburg, 71640, Germany
Not yet recruiting
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)München, 81377, Germany
Not yet recruiting
Universitaetsklinikum Essen | Klinik für Anaesthesiologie und IntensivmedizinEssen, 45147, Germany
Not yet recruiting
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB HaemostaseologieDresden, 01307, Germany
Not yet recruiting
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - LungenklinikKöln, 51109, Germany
Withdrawn
Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Klinik für Anaesthesiologie und Operative IntensivmedizinKiel, 24105, Germany
Not yet recruiting
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalenteLa Roche-Sur-Yon, 85000, France
Recruiting
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive RéanimationStrasbourg, 67091, France
Recruiting
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine HyperbareAngers, 49100, France
Recruiting
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalenteLimoges, 87042, France
Recruiting
Hopital Hotel Dieu Nantes - Service de Médecine Intensive RéanimationNantes, 44000, France
Recruiting
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive RéanimationTours, 37044, France
Not yet recruiting
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine HyperbareGarches, 92380, France

Primary Outcome

  • Occurrence of Disseminated Intravascular Coagulation (DIC) as defined by ISTH criteria
    The International Society on Thrombosis and Haemostasis (ISTH) developed a scoring system to aid in the diagnosis and management of DIC. The ISTH DIC score is a standardized tool that quantifies the severity of DIC based on specific laboratory parameters. The total score ranges from 0 to 8, with a score of ≥ 4 indicating overt DIC. In this study, the ISTH DIC score will be employed for screening purposes as well as to evaluate the presence and severity of DIC in participants enrolled.
    date_rangeTime Frame:
    Until Day 56

Secondary Outcome

  • Sequential Organ Failure Assessment (SOFA) score at baseline
    The Sequential Organ Failure Assessment (SOFA) score is a clinical tool used to track a patient's status in regard to the organ systems during stay in an Intensive Care Unit (ICU), assigning a score from 0 (normal function) to 4 (high degree of dysfunction) for each system. The total SOFA can range from 0 to 24.
    date_rangeTime Frame:
    At baseline
  • Change from baseline in SOFA score on Day 5 or End of ICU stay, whichever happens first
    The Sequential Organ Failure Assessment (SOFA) score is a clinical tool used to track a patient's status in regard to the organ systems during stay in an Intensive Care Unit (ICU), assigning a score from 0 (normal function) to 4 (high degree of dysfunction) for each system. The total SOFA can range from 0 to 24.
    date_rangeTime Frame:
    Baseline and Day 5 or End of ICU stay
  • All-cause mortality until Day 56
    date_rangeTime Frame:
    Until Day 56
  • Organ support status until Day 56
    Describe the type of organ support status and the time with organ support status.
    date_rangeTime Frame:
    Until Day 56
  • Hospitalization status until Day 56
    Describe the type of hospitalization (ICU [Intensive Care Unit]/ common ward/ discharge) and the time with hospitalization.
    date_rangeTime Frame:
    Until Day 56

Trial design

Exploratory study to investigate the association between the onset of disseminated intravascular coagulation (DIC) and disease progression with different biomarker candidates as well as standard clinical and demographic parameters in adult patients with sepsis.
Trial Type
Interventional
Intervention Type
Other
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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