UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005065
Receipt number 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 09:10:18

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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 or person

Institute

Osaka Saiseikai Senri Hospital

Institute

Department

Personal name



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

Value
https://center6.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