Clinical trial NCT06986798: A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Sepsis Associated DIC
Keywords: Sepsis
DIC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 Criteria:

* 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.

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 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.

Primary outcomes:
measure: Occurrence of Disseminated Intravascular Coagulation (DIC) as defined by ISTH criteria
timeFrame: Until Day 56
Secondary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) score at baseline
timeFrame: At baseline
measure: Change from baseline in SOFA score on Day 5 or End of ICU stay, whichever happens first
timeFrame: Baseline and Day 5 or End of ICU stay
measure: All-cause mortality until Day 56
timeFrame: Until Day 56
measure: Type of organ support status until Day 56
timeFrame: Until Day 56
measure: Time with organ support status until Day 56
timeFrame: Until Day 56
measure: Type of hospitalization status until Day 56
timeFrame: Until Day 56
measure: Time with hospitalization until Day 56
timeFrame: Until Day 56
Other outcomes:
Locations:
city: Graz
country: Austria
facility: MedUni Graz | Innere Medizin, ICU
city: Innsbruck
country: Austria
facility: MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin
city: Vienna
country: Austria
facility: MedUni Wien | Univ. Klinik für Klinische Pharmakologie
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Kennedylaan
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
city: Ottignies-Louvain-La-Neuve
country: Belgium
facility: Clinique Saint-Pierre d'Ottignies - Intensive Care
city: Woluwe Saint Lambert
country: Belgium
facility: Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
city: Garches
country: France
facility: Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
city: La Roche-Sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
city: Nantes
country: France
facility: Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
city: Essen
country: Germany
facility: Universitaetsklinikum Essen | Klinik für Anaesthesiologie und Intensivmedizin
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Klinik für Anaesthesiologie und Operative Intensivmedizin
city: Ludwigsburg
country: Germany
facility: RKH Klinikum Ludwigsburg
city: München
country: Germany
facility: Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Anestesia e TI Polivalente
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Carlo - Anestesia e Rianimazione
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica
city: Rozzano
country: Italy
facility: Humanitas Mirasole S.p.A. - Anestesia e Terapie Intensive
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente - Intensive Care
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum St. Radboud
city: Rotterdam
country: Netherlands
facility: Maasstad
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
Study officials:
References: