UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050749 |
|---|---|
| Receipt number | R000057674 |
| Scientific Title | Multicenter Observational Study to Evaluate Epidemiology, Diagnosis, and Treatment of Disseminated Intravascular Coagulation |
| Date of disclosure of the study information | 2023/04/02 |
| Last modified on | 2023/04/02 14:30:32 |
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Basic information
Public title
Multicenter Observational Study to Evaluate Epidemiology, Diagnosis, and Treatment of Disseminated Intravascular Coagulation
Acronym
Multicenter Observational Study for Disseminated Intravascular Coagulation
Scientific Title
Multicenter Observational Study to Evaluate Epidemiology, Diagnosis, and Treatment of Disseminated Intravascular Coagulation
Scientific Title:Acronym
Multicenter Observational Study for Disseminated Intravascular Coagulation
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Infectious disease |
| Surgery in general | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate epidemiology, diagnosis, and treatment of disseminated intravascular coagulation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short-term mortality (28day from admission, ICU discharge, hospital discharge)
Key secondary outcomes
Bleeding complication, multi-organ dysfunction, duration of mechanical ventilation, duration of dialysis, duration of catecholamine use, changes in laboratory data
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants requiring emergency hospitalization or ICU admission
Key exclusion criteria
Patients considered inappropriate for this study by the investigators
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Yamakawa |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka, Japan
TEL
0726831221
kazuma.yamakawa@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Yamakawa |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka, Japan
TEL
0726831221
Homepage URL
kazuma.yamakawa@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Kazuma Yamakawa
Funding Source
Organization
The Japanese Society on Thrombosis and Hemostasis
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigakumachi, Takatsuki, Osaka, Japan
Tel
0726831221
kazuma.yamakawa@ompu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter observational study evaluates the epidemiology, diagnosis, and treatment of disseminated intravascular coagulation. Medical data such as electrical clinical records, critical care department systems, and DPC data will be used to generate an integrated multicenter database. Clinical data will be collected prospectively and comprehensively, and retrospectively analyzed for resolving various clinical questions.
Management information
Registered date
| 2023 | Year | 04 | Month | 02 | Day |
Last modified on
| 2023 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057674
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
