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COMPLETED
NCT06986798
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A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis

Sponsor: Bayer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-01-29

Completion Date

2026-05-06

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (31)

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

Innsbruck, Tyrol, Austria

MedUni Graz | Innere Medizin, ICU

Graz, 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

CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation

Tours, Centre-Val de Loire, France

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

Strasbourg, Grand Est, France

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

Limoges, New Aquitaine, France

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

Angers, Pays de la Loire Region, France

Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente

La Roche-sur-Yon, Pays de la Loire Region, France

Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation

Nantes, Pays de la Loire Region, France

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

Garches, Île-de-France Region, 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, Overijssel, Netherlands

Maasstad

Rotterdam, South Holland, Netherlands

Universitair Medisch Centrum St. Radboud

Nijmegen, 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