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NCT Number: NCT06373159

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

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.

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Key information

Conditions

Sepsis Blood Coagulation Disorders Disseminated Intravascular Coagulation Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Septic Systemic Inflammatory Response Syndrome Thrombophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Tokyo, 100-8265, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No study intervention

Other

Retrospective observational study using Real World Data (RWD) in Japan without study intervention

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Number of participants per clinical characteristics

    Time frame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023

    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

  2. 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

    DIC: disseminated intravascular coagulation

  3. 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

    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

  4. 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

    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

  5. 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

    DIC: disseminated intravascular coagulation

  6. 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

    DIC: disseminated intravascular coagulation

  7. 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

    Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.

  8. 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

    DIC: disseminated intravascular coagulation

  9. 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

    DIC: disseminated intravascular coagulation

  10. 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

    Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Study for the Disseminated Intravascular Coagulation Among Patients With Sepsis in Japan: A Hospital-based Cohort Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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