UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048709 |
|---|---|
| Receipt number | R000055499 |
| Scientific Title | Development of a large multicenter chest CT registry system for the patients with severe acute respiratory distress syndrome requiring V-V ECMO in Japan: J-CARVE registry |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/02/21 14:47:15 |
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Basic information
Public title
Development of the Japan Chest CT for ARDS requiring V-V ECMO registry
Acronym
J-CARVE registry
Scientific Title
Development of a large multicenter chest CT registry system for the patients with severe acute respiratory distress syndrome requiring V-V ECMO in Japan: J-CARVE registry
Scientific Title:Acronym
J-CARVE registry
Region
| Japan |
Condition
Condition
ARDS
Classification by specialty
| Medicine in general | Pneumology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To register the chest CT findings of adult ARDS patients with V-V ECMO in Japan
Basic objectives2
Others
Basic objectives -Others
epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical informations in the patients in this registry
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ARDS patients with V-V ECMO
Key exclusion criteria
Cases who had been converted from V-A ECMO
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mitsuaki |
| Middle name | |
| Last name | Nishikimi |
Organization
Hiroshima University
Division name
Department of Emergency and Critical Care Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5456
m0528332626@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuaki |
| Middle name | |
| Last name | Nishikimi |
Organization
Hiroshima University
Division name
Department of Emergency and Critical Care Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5456
Homepage URL
https://www.ace-registry.net
m0528332626@yahoo.co.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB at Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
Tel
082-257-1551
iryo-seisaku@office.hiroshima-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
| 2022 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information including chest CT findings
Management information
Registered date
| 2022 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055499
