Clinical trial NCT06373159: An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan
Official title: A Study for the Disseminated Intravascular Coagulation Among Patients With Sepsis in Japan: A Hospital-based Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sepsis
Disseminated Intravascular Coagulation
Keywords: Thrombocytopenic sepsis
Septic shock
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 5740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Distribution of JAAM DIC score
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Distribution of ISTH DIC score
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Distribution of MHLW DIC score
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Distribution of SOFA score
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Days from sepsis diagnosis to the onset of DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Secondary outcomes:
measure: Number of participants per clinical characteristics
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
measure: Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC
timeFrame: Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Bayer
Study officials:
References: