UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019231
Receipt number 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 14:26:51

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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 or person

Institute

National Hospital Organization Kumamoto Medical Center

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


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

Value
https://center6.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