do_not_disturb_altRecruitment Complete

Sepsis, Disseminated intravascular coagulation

Bayer Identifier:

22643

ClinicalTrials.gov Identifier:

NCT06373159

EudraCT Number:

Not Available

EU CT Number:

Not Available
An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults with Sepsis in Japan

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - Sepsis patient cohort: None
    - Sepsis-associated DIC patient cohort: None
    - Non-sepsis-associated DIC patient cohort: Sepsis patients

Trial summary

Enrollment Goal
5740
Trial Dates
March 2024 - December 2025
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
BayerTokyo, 100-8265, Japan

Primary Outcome

  • Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up
    DIC: disseminated intravascular coagulation
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023

Secondary Outcome

  • 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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023

Trial design

A Study for the Disseminated Intravascular Coagulation Among Patients with Sepsis in Japan: A Hospital-based Cohort Study
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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