SepsisNCT06986798
A Study to Learn About the Occurrence of Disseminated Intravascular Coagulation in People With Sepsis and Further Worsening of Sepsis
A study testing Local standard medical care in people with Sepsis and Sepsis Associated DIC, run by Bayer at 31 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Sepsis Associated DIC
- What is being tested?
- Local standard medical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 31 sitesin 7 countries
- Study dates
- 29 Jan 2025to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
31 sites in 7 countries.
31 sites in 7 countries
France7 sites
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, Pays de la Loire Region, 49100
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
Garches, Île-de-France Region, 92380
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, Pays de la Loire Region, 85000
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
Limoges, New Aquitaine, 87042
Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
Nantes, Pays de la Loire Region, 44000
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
Strasbourg, Grand Est, 67091
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours, Centre-Val de Loire, 37044
Germany5 sites
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
Cologne, North Rhine-Westphalia, 51109
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
Dresden, 01307
Universitaetsklinikum Essen | Klinik für Anaesthesiologie und Intensivmedizin
Essen, 45147
RKH Klinikum Ludwigsburg
Ludwigsburg, 71640
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
München, 81377
Spain5 sites
Hospital Universitari Vall D Hebron | Unidad de Cuidados Intensivos
Barcelona, 08035
Hospital Universitario De Getafe | Unidad de Cuidados Intensivos
Getafe, Madrid, 28905
Hospital Clinico San Carlos | Unidad de Cuidados Intensivos
Madrid, 28040
Hospital Universitario Central De Asturias | Unidad de Cuidados Intensivos
Oviedo, Principality of Asturias, 33011
Hospital Universitario Virgen Del Rocio S.L. | Unidad de Cuidados Intensivos
Seville, 41013
Belgium4 sites
AZ Groeninge - Campus Kennedylaan
Kortrijk, 8500
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, 4000
Clinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies-Louvain-la-Neuve, 1340
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 1200
Italy4 sites
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Anestesia e TI Polivalente
Bologna, 40138
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Carlo - Anestesia e Rianimazione
Milan, 20153
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica
Roma, 00168
Humanitas Mirasole S.p.A. - Anestesia e Terapie Intensive
Rozzano, 20089
Austria3 sites
MedUni Graz | Innere Medizin, ICU
Graz, 8036
MedUni Innsbruck | Innere Medizin I, Internistische Intensiv- und Notfallmedizin
Innsbruck, Tyrol, 6020
MedUni Wien | Univ. Klinik für Klinische Pharmakologie
Vienna, 1090
Netherlands3 sites
Medisch Spectrum Twente - Intensive Care
Enschede, Overijssel, 7512 KZ
Universitair Medisch Centrum St. Radboud
Nijmegen, 6500HB
Maasstad
Rotterdam, South Holland, 3079 DZ
About this study
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
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.
Read more
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
- Being tested
- Local standard medical care
- Keywords
- Sepsis, DIC
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local standard medical careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Local standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until Day 56
Secondary outcomes (7)
Sequential Organ Failure Assessment (SOFA) score at baseline
The 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.
Measured: At baseline
Change from baseline in SOFA score on Day 5 or End of ICU stay, whichever happens first
The 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.
Measured: Baseline and Day 5 or End of ICU stay
All-cause mortality until Day 56
Measured: Until Day 56
Type of organ support status until Day 56
Describe the type of organ support status.
Measured: Until Day 56
Time with organ support status until Day 56
Describe the time with organ support status.
Measured: Until Day 56
Type of hospitalization status until Day 56
Describe the type of hospitalization (ICU [Intensive Care Unit]/ common ward/ discharge).
Measured: Until Day 56
Time with hospitalization until Day 56
Describe the time with hospitalization.
Measured: Until Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start29 Jan 2025
- Primary completion22 Dec 2025
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986798
- Sponsor's protocol ID
- 22795
- Status last verified
- May 2026
- First submitted
- 24 Apr 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06986798
- Acronym / sponsor ID
- 22795
- Conditions
- Sepsis, Sepsis Associated DIC
- Keywords
- Sepsis, DIC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic participants in ICU | Other | Other: Local standard medical careThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local standard medical careNo 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 | Septic participants in ICU |
Primary outcome
Occurrence of Disseminated Intravascular Coagulation (DIC) as defined by ISTH criteria
Time frame: Until Day 56
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.
7 secondary outcomes
Sequential Organ Failure Assessment (SOFA) score at baseline
Time frame: At baseline
Change from baseline in SOFA score on Day 5 or End of ICU stay, whichever happens first
Time frame: Baseline and Day 5 or End of ICU stay
All-cause mortality until Day 56
Time frame: Until Day 56
Type of organ support status until Day 56
Time frame: Until Day 56
Time with organ support status until Day 56
Time frame: Until Day 56
Type of hospitalization status until Day 56
Time frame: Until Day 56
Time with hospitalization until Day 56
Time frame: Until Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local standard medical care in people with Sepsis and Sepsis Associated DIC, run by Bayer at 31 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Germany, Spain, Belgium, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Disseminated Intravascular Coagulation (DIC) as defined by ISTH criteria (time frame: Until Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.