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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06373159
• Other study ID #: 22643
• Status: Active, not recruiting
• Start date: April 10, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5740
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disseminated Intravascular Coagulation
• Sepsis
• Toxemia

Intervention

Other:
• No study intervention
Retrospective observational study using Real World Data (RWD) in Japan without study intervention

Locations

Country	Name	City	State
Japan	Bayer	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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