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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Disseminated Intravascular Coagulation
• Intervention / Treatment: Other: No study intervention

• Study Type: Observational
• Enrollment (Actual): 5740

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 100-8265
    • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Retrospective observational study using Real World Data (RWD) in Japan without 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; Retrospective observational study using Real World Data (RWD) in Japan without study intervention
Non-sepsis-associated DIC patient cohort; DIC patients without sepsis in patient inclusion period	Other: No study intervention; Retrospective observational study using Real World Data (RWD) in Japan without study intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants per clinical characteristics	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	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	DIC: disseminated intravascular coagulation	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	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	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	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	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	DIC: disseminated intravascular coagulation	Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC	DIC: disseminated intravascular coagulation	Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC	Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.	Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC	DIC: disseminated intravascular coagulation	Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC	DIC: disseminated intravascular coagulation	Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC	Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.	Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Actual): November 27, 2025
• Study Completion (Actual): November 27, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Septic shock; Thrombocytopenic sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Shock; Thrombophilia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Sepsis; Shock, Septic; Disseminated Intravascular Coagulation
• Other Study ID Numbers: 22643

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No