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

NCT06373159 | Completed

• 1 other identifier: 22643
• Study Type: observational
• Target: 5,740
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Thrombocytopenic sepsis; Septic shock

Outcome Measures

Primary Outcomes (6)

• Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up

  DIC: disseminated intravascular coagulation

  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

  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

  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

  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

  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

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

Secondary Outcomes (10)

• Number of participants per clinical characteristics

  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

  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

  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

  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

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

Study Arms (3)

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

Other: No study intervention

Sepsis-associated DIC patient cohort

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

Other: No study intervention

Non-sepsis-associated DIC patient cohort

DIC patients without sepsis in patient inclusion period

Other: No study intervention

Interventions

No study intervention OTHER

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

Non-sepsis-associated DIC patient cohort; Sepsis patient cohort; Sepsis-associated DIC patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Sepsis patient cohort: None
• Sepsis-associated DIC patient cohort: None
• Non-sepsis-associated DIC patient cohort: Sepsis patients

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Tokyo, 100-8265, Japan

Location

MeSH Terms

Conditions

Sepsis; Disseminated Intravascular Coagulation; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 18, 2024
• Study Start: March 22, 2024
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)