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

NCT06986798 | Completed

• 1 other identifier: 22795
• Study Type: interventional
• Target: 150
• Locations: 7 countries
• Sites: 31

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.

Conditions

Sepsis; Sepsis Associated DIC

Keywords

Sepsis; DIC

Outcome Measures

Primary Outcomes (1)

• 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.

  Until Day 56

Secondary Outcomes (7)

• Sequential Organ Failure Assessment (SOFA) score at baseline

  At baseline

• Change from baseline in SOFA score on Day 5 or End of ICU stay, whichever happens first

  Baseline and Day 5 or End of ICU stay

• All-cause mortality until Day 56

  Until Day 56

• Type of organ support status until Day 56

  Until Day 56

• Time with organ support status until Day 56

  Until Day 56

Study Arms (1)

Septic participants in ICU

OTHER

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.

Other: Local standard medical care

Interventions

Local standard medical care OTHER

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.

Septic participants in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (31)

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

Innsbruck, Tyrol, 6020, Austria

Location

MedUni Graz | Innere Medizin, ICU

Graz, 8036, Austria

Location

MedUni Wien | Univ. Klinik für Klinische Pharmakologie

Vienna, 1090, Austria

Location

AZ Groeninge - Campus Kennedylaan

Kortrijk, 8500, Belgium

Location

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

Liège, 4000, Belgium

Location

Clinique Saint-Pierre d'Ottignies - Intensive Care

Ottignies-Louvain-la-Neuve, 1340, Belgium

Location

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

Woluwe-Saint-Lambert, 1200, Belgium

Location

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

Angers, 49100, France

Location

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

Garches, 92380, France

Location

Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente

La Roche-sur-Yon, 85000, France

Location

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

Limoges, 87042, France

Location

Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation

Nantes, 44000, France

Location

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

Strasbourg, 67091, France

Location

CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation

Tours, 37044, France

Location

Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik

Cologne, North Rhine-Westphalia, 51109, Germany

Location

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

Dresden, 01307, Germany

Location

Universitaetsklinikum Essen | Klinik für Anaesthesiologie und Intensivmedizin

Essen, 45147, Germany

Location

RKH Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Location

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

München, 81377, Germany

Location

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

Bologna, 40138, Italy

Location

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

Milan, 20153, Italy

Location

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

Roma, 00168, Italy

Location

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

Rozzano, 20089, Italy

Location

Medisch Spectrum Twente - Intensive Care

Enschede, 7512 KZ, Netherlands

Location

Universitair Medisch Centrum St. Radboud

Nijmegen, 6500HB, Netherlands

Location

Maasstad

Rotterdam, 3079 DZ, Netherlands

Location

Hospital Universitario De Getafe | Unidad de Cuidados Intensivos

Getafe, Madrid, 28905, Spain

Location

Hospital Universitario Central De Asturias | Unidad de Cuidados Intensivos

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitari Vall D Hebron | Unidad de Cuidados Intensivos

Barcelona, 08035, Spain

Location

Hospital Clinico San Carlos | Unidad de Cuidados Intensivos

Madrid, 28040, Spain

Location

Hospital Universitario Virgen Del Rocio S.L. | Unidad de Cuidados Intensivos

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 23, 2025
• Study Start: January 29, 2025
• Primary Completion: December 22, 2025
• Study Completion: February 2, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); NL (3); IT (4); FR (7); DE (5); ES (5); BE (4)