A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis
NCT ID: NCT06986798
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2025-01-29
2026-01-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Septic participants in ICU
The study population will consist of septic participants admitted to a medical intensive care unit (ICU), as defined in the inclusion criteria. No investigational study interventions will be administered in this study. Participants will undergo therapeutic and diagnostic procedures as per local standard medical care and as deemed appropriate by the treating physicians. Collection of blood and of available clinical data are the only activities performed in addition.
Local standard medical care
No investigational study interventions will be administered in this study. Participants will undergo therapeutic and diagnostic procedures as per local standard medical care and as deemed appropriate by the treating physicians. Collection of blood and of available clinical data are the only activities performed in addition.
Interventions
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Local standard medical care
No investigational study interventions will be administered in this study. Participants will undergo therapeutic and diagnostic procedures as per local standard medical care and as deemed appropriate by the treating physicians. Collection of blood and of available clinical data are the only activities performed in addition.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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MedUni Graz | Innere Medizin, ICU
Graz, , Austria
MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin
Innsbruck, , Austria
MedUni Wien | Univ. Klinik für Klinische Pharmakologie
Vienna, , Austria
AZ Groeninge - Campus Kennedylaan
Kortrijk, , Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, , Belgium
Clinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies-Louvain-la-Neuve, , Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, , Belgium
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, , France
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
Garches, , France
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, , France
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
Limoges, , France
Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
Nantes, , France
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
Strasbourg, , France
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours, , France
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
Dresden, , Germany
Universitaetsklinikum Essen | Klinik für Anaesthesiologie und Intensivmedizin
Essen, , Germany
RKH Klinikum Ludwigsburg
Ludwigsburg, , Germany
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
München, , Germany
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Anestesia e TI Polivalente
Bologna, , Italy
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Carlo - Anestesia e Rianimazione
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica
Roma, , Italy
Humanitas Mirasole S.p.A. - Anestesia e Terapie Intensive
Rozzano, , Italy
Medisch Spectrum Twente - Intensive Care
Enschede, , Netherlands
Universitair Medisch Centrum St. Radboud
Nijmegen, , Netherlands
Maasstad
Rotterdam, , Netherlands
Hospital Universitario De Getafe | Unidad de Cuidados Intensivos
Getafe, Madrid, Spain
Hospital Universitario Central De Asturias | Unidad de Cuidados Intensivos
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall D Hebron | Unidad de Cuidados Intensivos
Barcelona, , Spain
Hospital Clinico San Carlos | Unidad de Cuidados Intensivos
Madrid, , Spain
Hospital Universitario Virgen Del Rocio S.L. | Unidad de Cuidados Intensivos
Seville, , Spain
Countries
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Related Links
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Other Identifiers
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22795
Identifier Type: -
Identifier Source: org_study_id
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