Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-25
Brief Title:
An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Study for the Disseminated Intravascular Coagulation Among Patients With Sepsis in Japan A Hospital-based Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an observational study in which data already collected from people with sepsis blood poisoning andor 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None