SepsisNCT06373159
An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan
An observational study of Sepsis and Disseminated Intravascular Coagulation, run by Bayer at 1 site in Japan.
Trial summary
This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied. In observational studies, only observations are made without participants receiving any advice or changes to their healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Disseminated Intravascular Coagulation
- What is being tested?
- No study intervention
- How many people
- 5,740 participants
- Where
- 1 siteJapan
- Study dates
- 22 Mar 2024to 27 Nov 2025
- Phase
- Observational
- 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
Study population: Source population are patients in hospitals providing electronic medical record (EMR) and diagnosis procedure combination (DPC) data to TXP Medical in Japan.
Who may be able to join
- Sepsis patient cohort
- Sepsis patients
- Age ≥18 years
- Subgroups:
- Sepsis with thrombocytopenia patient cohort
- Septic shock patient cohort
Show all 21Show fewer
- Sepsis-associated DIC patient cohort
- DIC patients in sepsis patient cohort
- Subgroups:
- Organ failure: kidney (Serum creatinine (SCr) < 1.2 mg/dl and ≥ 1.2 mg/dl)
- Organ failure: liver (bilirubin < 1.2 mg/dl and ≥ 1.2 mg/dl)
- Organ failure: cardiovascular (with and without catecholamine or vasopressin)
- With low molecular weight (LMW) heparins, unfractionated heparins, and both
- With and without DIC treatment
- Priority 1_Anticoagulants specifically used in Japan (recombinant antithrombin, recombinant thrombomodulin, human anti-thrombin III)
- Priority 1 + Priority 2_Drugs for sepsis-associated DIC (LMW heparins, unfractionated heparins, protease inhibitors)
- Priority 1 + Priority 2 + Priority 3_antibiotics (antifungals), and/or steroids
- Non-sepsis-associated DIC patient cohort
- Hematopoietic malignant tumor patients
- DIC patients
- Age ≥18 years
Who cannot join
- Sepsis patient cohort: None
- Sepsis-associated DIC patient cohort: None
- Non-sepsis-associated DIC patient cohort: Sepsis patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study for the Disseminated Intravascular Coagulation Among Patients With Sepsis in Japan: A Hospital-based Cohort Study
This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.
In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.
Read more
DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.
To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.
In this study, researchers will assess patient data from a hospital database in Japan.
The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.
To learn about this, researchers will collect the following information:
- The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis
- The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)
- The number of days between diagnosis of sepsis and the beginning of DIC
Researchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.
In this study, only available data from routine care are collected.
- Conditions
- Sepsis, Disseminated Intravascular Coagulation
- Being tested
- No study intervention
- Keywords
- Thrombocytopenic sepsis, Septic shock
- Medical subject headings
- Sepsis, Disseminated Intravascular Coagulation, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study interventionOther
Retrospective observational study using Real World Data (RWD) in Japan without study intervention
| Study group | Role | What they receive |
|---|---|---|
| Sepsis patient cohort | Patients diagnosed with sepsis in patient inclusion period, regardless of etiology, including subgroups: sepsis with thrombocytopenia patient cohort and septic shock patient cohort Receives: Other: No study intervention | |
| Sepsis-associated DIC patient cohort | Sepsis patients with onset of DIC in the patient record in patient inclusion period Receives: Other: No study intervention | |
| Non-sepsis-associated DIC patient cohort | DIC patients without sepsis in patient inclusion period Receives: Other: No study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up
DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Distribution of JAAM DIC score
The Japanese Association for Acute Medicine (JAAM) DIC scoring algorithm includes a number of variables but in addition specific criteria for evidence of a Systemic Inflammatory Response Syndrome (SIRS). JAAM DIC score >= 4 supports a diagnosis of DIC. DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Distribution of ISTH DIC score
The International Society on Thrombosis Haemostasis (ISTH) DIC score is a simple scoring system produced by the ISTH group for the diagnosis of DIC depending on the Platelet count, the PT, the fibrinogen level and critically the FDP/D-Dimer results. A total score of ≥5 = DIC as long as the score is associated with a clinical disorder known to cause DIC. DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Distribution of MHLW DIC score
The Japanese Ministry of Health, Labor and Welfare (MHLW) DIC score is a scoring system for the diagnosis of overt DIC. MHLW DIC score ≥7 is defined as DIC. DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Distribution of SOFA score
The Sequential Organ Failure Assessment (SOFA) score is a scoring system based on performance of respiratory, coagulation, liver, cardiovascular, central nervous system, and kidney. The higher the SOFA score, the higher the likely mortality. DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Days from sepsis diagnosis to the onset of DIC
DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Secondary outcomes (10)
Number of participants per clinical characteristics
Clinical characteristics (e.g., demographics, comorbidities, medical history) in patients with sepsis, thrombocytopenic sepsis and septic shock, respectively; in patients with sepsis in different definitions (diagnosis codes, laboratory values, and procedure codes); at the onset of DIC in patients who developed sepsis-associated DIC. DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC
DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC
Clinical outcomes are assessed at 14 days, 28 days, 60 days, 183 days, 365 days (1 year) and 730 days (2 years) of follow up. Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization. DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC
Clinical outcomes are assessed at 14 days, 28 days, 60 days, 183 days, 365 days (1 year) and 730 days (2 years) of follow up. Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization. DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC
DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC
DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC
Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC
DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC
DIC: disseminated intravascular coagulation
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC
Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.
Measured: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start22 Mar 2024
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373159
- Sponsor's protocol ID
- 22643
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2024
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for the Disseminated Intravascular Coagulation Among Patients With Sepsis in Japan: A Hospital-based Cohort Study
- ClinicalTrials.gov ID
- NCT06373159
- Acronym / sponsor ID
- 22643
- Conditions
- Sepsis, Disseminated Intravascular Coagulation
- Keywords
- Thrombocytopenic sepsis, Septic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,740 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 18 Apr 2024 (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 observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.
In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.
DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.
To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.
In this study, researchers will assess patient data from a hospital database in Japan.
The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.
To learn about this, researchers will collect the following information:
- The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis
- The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)
- The number of days between diagnosis of sepsis and the beginning of DIC
Researchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.
In this study, only available data from routine care are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepsis patient cohort | – | Other: No study interventionPatients diagnosed with sepsis in patient inclusion period, regardless of etiology, including subgroups: sepsis with thrombocytopenia patient cohort and septic shock patient cohort |
| Sepsis-associated DIC patient cohort | – | Other: No study interventionSepsis patients with onset of DIC in the patient record in patient inclusion period |
| Non-sepsis-associated DIC patient cohort | – | Other: No study interventionDIC patients without sepsis in patient inclusion period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Source population are patients in hospitals providing electronic medical record (EMR) and diagnosis procedure combination (DPC) data to TXP Medical in Japan.
Key inclusion criteria (21 listed)
- Sepsis patient cohort
- Sepsis-associated DIC patient cohort
- Non-sepsis-associated DIC patient cohort
Key exclusion criteria (3 listed)
- Sepsis patient cohort: None
- Sepsis-associated DIC patient cohort: None
- Non-sepsis-associated DIC patient cohort: Sepsis patients
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 |
|---|---|---|
| No study interventionRetrospective observational study using Real World Data (RWD) in Japan without study intervention | Other | Non-sepsis-associated DIC patient cohort, Sepsis patient cohort, Sepsis-associated DIC patient cohort |
Primary outcome
Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
DIC: disseminated intravascular coagulation
Distribution of JAAM DIC score
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
The Japanese Association for Acute Medicine (JAAM) DIC scoring algorithm includes a number of variables but in addition specific criteria for evidence of a Systemic Inflammatory Response Syndrome (SIRS). JAAM DIC score >= 4 supports a diagnosis of DIC. DIC: disseminated intravascular coagulation
Distribution of ISTH DIC score
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
The International Society on Thrombosis Haemostasis (ISTH) DIC score is a simple scoring system produced by the ISTH group for the diagnosis of DIC depending on the Platelet count, the PT, the fibrinogen level and critically the FDP/D-Dimer results. A total score of ≥5 = DIC as long as the score is associated with a clinical disorder known to cause DIC. DIC: disseminated intravascular coagulation
Distribution of MHLW DIC score
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
The Japanese Ministry of Health, Labor and Welfare (MHLW) DIC score is a scoring system for the diagnosis of overt DIC. MHLW DIC score ≥7 is defined as DIC. DIC: disseminated intravascular coagulation
Distribution of SOFA score
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
The Sequential Organ Failure Assessment (SOFA) score is a scoring system based on performance of respiratory, coagulation, liver, cardiovascular, central nervous system, and kidney. The higher the SOFA score, the higher the likely mortality. DIC: disseminated intravascular coagulation
Days from sepsis diagnosis to the onset of DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
DIC: disseminated intravascular coagulation
10 secondary outcomes
Number of participants per clinical characteristics
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC
Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
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 21 Jan 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Disseminated Intravascular Coagulation, run by Bayer at 1 site in Japan.
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 21 inclusion and 3 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up (time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023). The study lists 6 primary outcomes in all. 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 21 Jan 2026.