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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001607
Receipt No. R000001930
Scientific Title The new Chain of Survival Concept to improve the neurologic outcome after cardiac arrest: Aizu Chain of Survival Concept Campaign
Date of disclosure of the study information 2009/01/01
Last modified on 2012/07/31

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Basic information
Public title The new Chain of Survival Concept to improve the neurologic outcome after cardiac arrest: Aizu Chain of Survival Concept Campaign
Acronym Aizu Chain of Survival Concept Campaign
Scientific Title The new Chain of Survival Concept to improve the neurologic outcome after cardiac arrest: Aizu Chain of Survival Concept Campaign
Scientific Title:Acronym Aizu Chain of Survival Concept Campaign
Region
Japan

Condition
Condition Cardiopulmonary arrest on arrival(CPAOA)
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An objective of this study is to examine the efficacy of the new Chain of Survival Concept for patients in CPAOA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A proportion of patients with favorable outcome (CPC1 or 2) assessed with the Glasgow-Pittsburgh Cerebral Performance and Overall Performance Categories at 1 month.
Key secondary outcomes

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients in cardiac arrest on arrival at hospital. Regardless of the presence of recovery of spontaneous circulation (ROSC) before arrival.
2)Patients resuscitated by 2005 American Heart Association Guideline for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.
3)Regardless of existence or nonexistence of witness.
4)Regardless of with or without bystander cardiopulmonary resuscitation (CPR).
Key exclusion criteria 1)Patients aged below 15
2)Patients in cardiac arrest associated with terminal stage of cancer.
3)Patients in cardiac arrest due to cerebrovascular disease.
4)Patients in cardiac arrest due to aortic dissection or aortic aneurysm
5)Family or other agents refuse to the registry of patient.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Tagami
Organization Aizu chuo hospital
Division name Department of Emergency & Critical Care Medicine
Zip code
Address 1-1 Tsuruga, Aizuwakamatsu, Fukushima, Japan
TEL 0242-25-1515
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Tagami
Organization Aizu chuo hospital
Division name Department of Emergency & Critical Care Medicine
Zip code
Address
TEL 0242-25-1515
Homepage URL
Email tagami@onchikai.jp

Sponsor
Institute Aizu chuo hospital
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 会津中央病院

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 01 Day

Related information
URL releasing protocol http://circ.ahajournals.org/content/126/5/589.full
Publication of results Published

Result
URL related to results and publications http://circ.ahajournals.org/content/126/5/589.full.pdf+html
Number of participants that the trial has enrolled
Results Circulation.
2012; 126: 589-597
doi: 10.1161/&#8203;CIRCULATIONAHA.111.086173
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
2008 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 06 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information Patients resuscitated by 2005 American Heart Association Guideline for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care after cardiac arrest will be referred to the tertiary care hospital for further intensive care treatment. The goal of the study is to improve the neurologic outcome after cardiac arrest by the new chain of survival.

Management information
Registered date
2008 Year 12 Month 27 Day
Last modified on
2012 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001930

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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