UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007528 |
|---|---|
| Receipt number | R000008833 |
| Scientific Title | Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2022/02/25 18:05:18 |
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Basic information
Public title
Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Acronym
Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Scientific Title
Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Scientific Title:Acronym
Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Region
| Japan |
Condition
Condition
Cardiac arrest
Classification by specialty
| Cardiology | Pediatrics | Emergency medicine |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the standard of adequate transport system and verify the effectiveness of post-hospital care, we lunch comprehensive cohort registry so that we could evaluate out-of- and in-hospital cares.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
One-month survivalor 90days survivalor with favorable neurological outcome, defined as CPC category 1 or 2.
Key secondary outcomes
Return ofspontaneous circulation,admission to the hospital,and 1-month survival or 90days survaival.
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
| 1 | days-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
General public living in Osaka ,those who had an OHCA and who were treated by EMS personnel, and then transported to medical institutions.
Key exclusion criteria
1.In hospital death(IHCA) cases
2.General public living in outof Osaka.
Target sample size
150000
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Health service
Zip code
606-8501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501
TEL
075-753-2431
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Health service
Zip code
606-8501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501
TEL
075-753-2431
Homepage URL
iwami.taku.8w@kyoto-u.ac.jp
Sponsor or person
Institute
kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT) Scientific Research Grant Fund Base Study (B)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2012 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2028 | Year | 05 | Month | 31 | Day |
Other
Other related information
This study is led by the Japanese Association for Acute Medicine (JAAM).
Management information
Registered date
| 2012 | Year | 03 | Month | 19 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008833
