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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036490
Receipt No. R000041577
Scientific Title Study of Advanced Cardiac Life Support for Ventricular Fibrillation with Extracorporeal Circulation in Japan
Date of disclosure of the study information 2019/04/15
Last modified on 2019/10/14

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Basic information
Public title Study of Advanced Cardiac Life Support for Ventricular Fibrillation with Extracorporeal Circulation in Japan
Acronym SAVE-J II study
Scientific Title Study of Advanced Cardiac Life Support for Ventricular Fibrillation with Extracorporeal Circulation in Japan
Scientific Title:Acronym SAVE-J II study
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 objective of this study is to examine the efficacy of extracorporeal cardiopulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA) patients in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is a favorable outcome at hospital discharge. A favorable outcome is defined as Cerebral Performance Category (CPC) of 1 or 2, whereas an unfavorable outcome is defined as a CPC of 3-5.
Key secondary outcomes 1) Favorable outcome at 1 month
2) Survival rate at hospital discharge and 1 month
3) Complications (bleeding, ischemia, infection)

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 1) OHCA
2) Receiving ECPR
Key exclusion criteria Family or other agents refuse to the registry of patient
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name Akihiko
Middle name
Last name Inoue
Organization Kagawa University
Division name Faculty of Medicine, Graduate School of Medicine
Zip code 761-0793
Address 1750-1 Ikenobe, Miki-cho, Kita, Kagawa
TEL 087-981-2392
Email a-inoue@hemc.jp

Public contact
Name of contact person
1st name Akihiko
Middle name
Last name Inoue
Organization Kagawa University
Division name Faculty of Medicine, Graduate School of Medicine
Zip code 761-0793
Address 1750-1 Ikenobe, Miki-cho, Kita, Kagawa
TEL 087-981-2392
Homepage URL
Email savej2-group@umin.ac.jp

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization This work was supported by JSPS KAKENHI Grant Number 19K09419.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kagawa University
Address 1750-1 Ikenobe, Miki-cho, Kita, Kagawa
Tel 087-981-2392
Email s17d701@stu.kagawa-u.ac.jp

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
2019 Year 04 Month 15 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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 25 Day
Date of IRB
2019 Year 01 Month 25 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a multicenter retrospective observational study of ECPR for OHCA patients.

Management information
Registered date
2019 Year 04 Month 12 Day
Last modified on
2019 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041577

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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