UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036490 |
|---|---|
| Receipt number | 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 | 2022/10/14 10:22:43 |
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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
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
savej2-group@umin.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041577
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