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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000007528 |
Receipt No. | 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 |
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 |
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Condition | ||||||
Condition | Cardiac arrest | |||||
Classification by specialty |
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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 |
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Age-upper limit |
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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.
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Key exclusion criteria | 1.In hospital death(IHCA) cases
2.General public living in outof Osaka. |
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Target sample size | 150000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | kyoto University |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Education, Culture, Sports, Science and Technology (MEXT) Scientific Research Grant Fund Base Study (B)
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | This study is led by the Japanese Association for Acute Medicine (JAAM). |
Management information | |||||||
Registered date |
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Last modified on |
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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 |