account_circleRecruiting
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.
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
AllAge
18 - N/ATrial summary
Enrollment Goal
150Trial Dates
January 2025 - April 2026Phase
N/ACould I Receive a placebo
NoProducts
No DrugAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Hospital Universitari Vall d'Hebron | Barcelona, 08035, Spain |
Not yet recruiting | Hospital Virgen del Rocio | Sevilla, 41013, Spain |
Not yet recruiting | Hospital Universitario de Getafe | Getafe, 28905, Spain |
Recruiting | Hospital Clinico San Carlos | Madrid, 28040, Spain |
Not yet recruiting | Hospital Central de Asturias | Oviedo, 33011, Spain |
Not yet recruiting | Clinique Saint-Pierre d'Ottignies - Intensive Care | Ottignies-Louvain-La-Neuve, 1340, Belgium |
Recruiting | Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman | Liège, 4000, Belgium |
Recruiting | AZ Groeninge - Campus Kennedylaan | Kortrijk, 8500, Belgium |
Not yet recruiting | Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc | Woluwe Saint Lambert, 1200, Belgium |
Not yet recruiting | Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Carlo - Anestesia e Rianimazione | Milano, 20153, Italy |
Not yet recruiting | Humanitas Mirasole S.p.A. - Anestesia e Terapie Intensive | Rozzano, 20089, Italy |
Not yet recruiting | Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Anestesia e TI Polivalente | Bologna, 40138, Italy |
Not yet recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica | Roma, 00168, Italy |
Not yet recruiting | Maasstad | Rotterdam, 3079 DZ, Netherlands |
Not yet recruiting | Universitair Medisch Centrum St. Radboud | Nijmegen, 6500HB, Netherlands |
Recruiting | Medisch Spectrum Twente - Intensive Care | Enschede, 7512 KZ, Netherlands |
Not yet recruiting | MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin | Innsbruck, 6020, Austria |
Not yet recruiting | MedUni Graz | Innere Medizin, ICU | Graz, 8036, Austria |
Not yet recruiting | MedUni Wien | Univ. Klinik für Klinische Pharmakologie | Vienna, 1090, Austria |
Not yet recruiting | RKH Klinikum Ludwigsburg | Ludwigsburg, 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 Intensivmedizin | Essen, 45147, Germany |
Not yet recruiting | Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie | Dresden, 01307, Germany |
Not yet recruiting | Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik | Köln, 51109, Germany |
Withdrawn | Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Klinik für Anaesthesiologie und Operative Intensivmedizin | Kiel, 24105, Germany |
Not yet recruiting | Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente | La Roche-Sur-Yon, 85000, France |
Recruiting | Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation | Strasbourg, 67091, France |
Recruiting | Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare | Angers, 49100, France |
Recruiting | Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente | Limoges, 87042, France |
Not yet recruiting | Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation | Nantes, 44000, France |
Not yet recruiting | CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation | Tours, 37044, France |
Not yet recruiting | Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare | Garches, 92380, France |
Primary Outcome
- Occurrence of Disseminated Intravascular Coagulation (DIC) as defined by ISTH criteriaThe 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:Between January 2025 and April 2026
Secondary Outcome
- Sequential Organ Failure Assessment (SOFA) score at baselineThe 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 firstdate_rangeTime Frame:Baseline and Day 5 or End of ICU stay
- All-cause mortality until Day 56date_rangeTime Frame:Until Day 56
- Organ support status until Day 56date_rangeTime Frame:Until Day 56
- Hospitalization status until Day 56date_rangeTime Frame:Until Day 56
Trial design
Trial Type
InterventionalIntervention Type
OtherTrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1