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

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 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

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

Value
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