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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019231
Receipt No. R000022071
Scientific Title The evaluation of the density ratio of grey to white matter on initial head CT for predicting neurological outcome after out-of hospital cardiac arrest patients
Date of disclosure of the study information 2015/10/05
Last modified on 2018/04/24

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Basic information
Public title The evaluation of the density ratio of grey to white matter on initial head CT for predicting neurological outcome after out-of hospital cardiac arrest patients
Acronym GWR-OHCA study
Scientific Title The evaluation of the density ratio of grey to white matter on initial head CT for predicting neurological outcome after out-of hospital cardiac arrest patients
Scientific Title:Acronym GWR-OHCA study
Region
Japan

Condition
Condition out-of-hospital cardiac arrest patients who returned of spontaneous circulation
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical usefulness of the density ratio of grey to white matter on initial head CT for predicting neurological outcome in out-of hospital cardiac arrest who returned of spontaneous circulation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neurological outcome on Day 30
Key secondary outcomes Mortality on Day 30

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria out-of-hospital cardiac arrest patients who returned of spontaneous circulation
Key exclusion criteria 1. Cardiac arrest patients due to trauma or stroke
2. Organic brain disease patients in whom the density of grey to white matter can not be evaluated
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Harada
Organization National Hospital Organization Kumamoto Medical Center
Division name Department of Emergency and Intensive Care Medicine
Zip code
Address 1-5, Ninomaru, Chuo-ku, Kumamoto, Japan
TEL 096-353-6501
Email masakoh@kumamed.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Harada
Organization National Hospital Organization Kumamoto Medical Center
Division name Department of Emergency and Intensive Care Medicine
Zip code
Address 1-5, Ninomaru, Chuo-ku, Kumamoto, Japan
TEL 096-353-6501
Homepage URL
Email masakoh@kumamed.jp

Sponsor
Institute National Hospital Organization Kumamoto Medical Center
Institute
Department

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

Other related organizations
Co-sponsor
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 国立病院機構の救命救急センター
Emergency and Critical Care Center of National Hospital Organization

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 05 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 Completed
Date of protocol fixation
2015 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Study design
Multi-center prospective cohort study
2. The patients of study
Out-of-hospital cardiac arrest patients who returned spontaneous circulation between November 2015 and Mar 2018
3. Data collection
1) Basic patient data (Age, Sex)
2) Pre-hospital information (Witness of cardiac arrest, bystander cardiopulmonary resuscitation, primary ECG)
3) post-admission information (Time of resuscitation, Time between CT and return of spontaneous circulation, Cause of cardiac arrest)
4) Treatment (Targeted temperature management)
5) Outcome (Neurological outcome on Day 30, Mortality on Day 30)
6) Hounsfield units of grey and white matter

Management information
Registered date
2015 Year 10 Month 04 Day
Last modified on
2018 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022071

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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