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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005065
Receipt No. R000005874
Scientific Title The prospective observational multi-center study about regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest
Date of disclosure of the study information 2011/04/01
Last modified on 2014/07/23

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Basic information
Public title The prospective observational multi-center study about regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest
Acronym J-POP trial (Prediction of neurological Outcomes in patients Post cardiac arrest trial)
Scientific Title The prospective observational multi-center study about regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest
Scientific Title:Acronym J-POP trial (Prediction of neurological Outcomes in patients Post cardiac arrest trial)
Region
Japan

Condition
Condition Out-of-hospital cardiac arrest
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the capability of regional brain oxygen saturation (rSO2) obtained immediately on arrival at the hospital to predict neurological outcomes in patients after out-of hospital cardiac arrest.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes CPC (Glasgow-Pittsburgh Cerebral Performance Categories) at 30 days and 3 months after out-of hospital cardiac arrest.
Key secondary outcomes CPC (Glasgow-Pittsburgh Cerebral Performance Categories) at hospital discharge

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with cardiac arrest on arrival after out-of hospital cardiac arrest, or patients with return to spontaneous circulation and comatose on arrival after out-of hospital cardiac arrest
Key exclusion criteria Out-of hospital cardiac arrest from a traumatic origin with uncontrolled bleeding, or patients with previous completion of a <Do Not Attempt Resuscitation> form
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Nishiyama
Organization Kyoto University Graduate School of Medicine
Division name Department of Primary Care and Emergency Medicine
Zip code
Address 54 Kawahara-chou, Shogoin, Sakyo-ku, 606-8507 Japan
TEL 0757513126
Email keinishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Nishiyama
Organization Kyoto University Graduate School of Medicine
Division name Department of Primary Care and Emergency Medicine
Zip code
Address 54 Kawahara-chou, Shogoin, Sakyo-ku, 606-8507 Japan
TEL 0757513126
Homepage URL
Email keinishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Osaka Saiseikai Senri Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Primary Care and Emergency Medicine, Kyoto University Graduate
School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪市立総合医療センター 救命救急センター(大阪府)
東北大学 高度救命救急センター (宮城県)
奈良県立医科大学 高度救命救急センター(奈良県)
藤沢市民病院 救命救急センター(神奈川県)
岐阜大学 高度救命救急センター(岐阜県)
京都桂病院(京都府)
慶應義塾大学 救急科(東京都)
国立病院機構 京都医療センター 循環器内科、救命救急センター(京都府)
済生会横浜市東部病院 救命救急センター(神奈川県)
福岡大学病院 救命救急センター(福岡県)
獨協医科大学(栃木県)
聖隷三方原病院(静岡県)
聖路加国際病院(東京都)
三重大学(三重県)
武蔵野赤十字病院(東京都)
京都大学医学研究科 初期診療・救急医学分野(京都府)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pubmed/24606889
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24606889
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 Completed
Date of protocol fixation
2011 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 11 Month 30 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 06 Month 01 Day
Date analysis concluded
2014 Year 09 Month 01 Day

Other
Other related information This study is prospective observational multi center study. In this study receiver operating characteristic (ROC) analysis is performed to evaluate the diagnostic accuracy of rSO2 in predicting good neurological outcome (CPC1,2) in patients after out-of hospital cardiac arrest.

Management information
Registered date
2011 Year 02 Month 10 Day
Last modified on
2014 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005874

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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