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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001403
Receipt No. R000001692
Scientific Title Study of Advanced life support for Ventricular fibrillation with Extracorporeal circulation in Japan
Date of disclosure of the study information 2008/10/01
Last modified on 2012/10/30

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Basic information
Public title Study of Advanced life support for Ventricular fibrillation with Extracorporeal circulation in Japan
Acronym SAVE-J
Scientific Title Study of Advanced life support for Ventricular fibrillation with Extracorporeal circulation in Japan
Scientific Title:Acronym SAVE-J
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 cardiopulmonary resuscitation with PCPS 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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients who had ventricular fibrillation (VF) or pulseless ventricular tachycardia on the initial electrocardiography.
2)Patients in cardiac arrest on arrival at hospital. Regardless of the presence of recovery of spontaneous circulation (ROSC) before arrival.
3)Patients who arrived at hospital within 45 minutes after the call for an ambulance or cardiac arrest.
4)Patients in cardiac arrest for more than 15 minutes after arrival at hospital.
5)Regardless of existence or nonexistence of witness.
6)Regardless of with or without bystander cardiopulmonary resuscitation (CPR).
Key exclusion criteria 1)Patients aged below 19 or above 75.
2)Patients with worse ADL (Activities of Daily Livings) function.
3)Patients in cardiac arrest due to non-cardiac diseases.
4)Deep body temperature less than 30 degree centigrade.
5)Family or other agents refuse to the registry of patient.
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Sakamoto, MD
Organization Teikyo University School of Medicine, Teikyo University Hospital
Division name Trauma and Critical Care Center
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL 03-3964-2898
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Aoki, MD, PhD, MS, MBA
Organization Center for Health Service, Outcomes Research and Development-Japan (CHORD-J)
Division name SAVE-J Data Management Center
Zip code
Address
TEL 03-5685-7475
Homepage URL http://www.save-j.net/
Email save-j@chord-j.info

Sponsor
Institute Teikyo University School of Medicine, Teikyo University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2008 Year 10 Month 01 Day

Related information
URL releasing protocol http://www.save-j.net/?page_id=32
Publication of results Partially published

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
2008 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Each institute chooses treatment with or without PCPS based on the care which is usually performed in each institute.
Ultimately, the responsible institute confirms the eligibility of each institute and decides the treatment protocol.
We compare PCPS group and non-PCPS group with the proportion of patients with favorable outcome (CPC1 or 2).

Management information
Registered date
2008 Year 09 Month 30 Day
Last modified on
2012 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001692

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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