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NCT06373159
An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan
trial testing No study intervention in Sepsis in 5,740 participants. Completed in 27 November 2025.
27 November 2025
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 5,740 |
| Start date | 22 March 2024 |
| Primary completion | 27 November 2025 |
| Estimated completion | 27 November 2025 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- No study intervention
Conditions studied
- Sepsis — all drugs for Sepsis →
- Disseminated Intravascular Coagulation — all drugs for Disseminated Intravascular Coagulation →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Sepsis or Disseminated Intravascular Coagulation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06373159
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06373159 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 21 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06373159.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing