An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan

Bayer

Status: Active, not recruiting

Conditions: Disseminated Intravascular Coagulation; Sepsis

Treatments: Other: No study intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06373159

22643

Details and patient eligibility

About

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.

Enrollment: 5,740 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,740 participants in 3 patient groups

Sepsis patient cohort

Description:

Patients diagnosed with sepsis in patient inclusion period, regardless of etiology, including subgroups: sepsis with thrombocytopenia patient cohort and septic shock patient cohort

Treatment:

Other: No study intervention

Sepsis-associated DIC patient cohort

Description:

Sepsis patients with onset of DIC in the patient record in patient inclusion period

Treatment:

Other: No study intervention

Non-sepsis-associated DIC patient cohort

Description:

DIC patients without sepsis in patient inclusion period

Treatment:

Other: No study intervention