UMIN-CTR Clinical Trial

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
Email	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
Email	iwami.taku.8w@kyoto-u.ac.jp

Sponsor
Institute	kyoto University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008833

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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