UMIN-CTR Clinical Trial

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	https://square.umin.ac.jp/save-j2/index.html
Publication of results	Published

Result
URL related to results and publications	https://ccforum.biomedcentral.com/articles/10.1186/s13054-022-03998-y
Number of participants that the trial has enrolled	2157
Results	In this large cohort, data on the ECPR of 1644 patients with OHCA show that the proportion of favorable neurological outcomes at hospital discharge was 14.1% and survival rate at hospital discharge was 27.2%. Complications were observed during ECPR in 32.7% of patients, and the most common complication was bleeding, with the rates of cannulation site bleeding and other types of hemorrhage at 16.4% and 8.5%, respectively.
Results date posted	2022 Year 10 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Ou-of-hospital cardiac arrest ECPR
Participant flow	All OHCA patients receiving ECPR from January 2013 to December 2018. Inclusion criteria: 18 years and older, OHCA, receiving ECPR Exclusion criteria: Family or other agents refuse to the registry of patient
Adverse events	Complications (bleeding, ischemia, and infection)
Outcome measures	Primary outcome: Favorable outcome at hospital discharge which is defined as Cerebral Performance Category (CPC) of 1 or 2. Secondary outcome: Favorable outcome at 1 month, Survival rate at hospital discharge and 1 month, Complications.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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 07 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
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	2022 Year 10 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041577