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Massive study reveals how often sepsis leads to dangerous clotting

NCT ID NCT06373159

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at health records from over 5,700 adults in Japan with sepsis (blood poisoning) to see how many also developed a serious blood clotting disorder called DIC. Researchers collected information from hospital databases to track DIC rates and severity scores. The goal was to better understand this complication in a country where specific DIC treatments are approved.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

5,740 people

The number who actually took part.

Started

Mar 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Source population are patients in hospitals providing electronic medical record (EMR) and diagnosis procedure combination (DPC) data to TXP Medical in Japan.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sepsis patient cohort * Sepsis patients * Age ≥18 years * Subgroups: * Sepsis with thrombocytopenia patient cohort * Septic shock patient cohort * 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 Exclusion Criteria: * Sepsis patient cohort: None * Sepsis-associated DIC patient cohort: None * Non-sepsis-associated DIC patient cohort: Sepsis patients

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Conditions

The condition(s) this trial relates to.

disseminated intravascular coagulation hematopoietic and lymphoid system neoplasm infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Disseminated intravascular coagulation Sepsis

Contacts and locations

Locations

  • Bayer

    Tokyo, 100-8265, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.