UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043930 |
|---|---|
| Receipt number | R000050164 |
| Scientific Title | Prospective validation study of CAST score and rCAST for adult PCAS patients before initiating TTM; SOS-KANTO 2017 |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2023/04/18 15:09:47 |
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Basic information
Public title
Prospective validation study of CAST score and rCAST for adult PCAS patients before initiating TTM; SOS-KANTO 2017
Acronym
Validation study of CAST score for PCAS patients
Scientific Title
Prospective validation study of CAST score and rCAST for adult PCAS patients before initiating TTM; SOS-KANTO 2017
Scientific Title:Acronym
Validation study of CAST score for PCAS patients
Region
| Japan |
Condition
Condition
Patients with post-cardiac arrest syndrome
Classification by specialty
| Medicine in general | Neurology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective validation of CAST and rCAST
Basic objectives2
Others
Basic objectives -Others
AUCs of CAST and rCAST
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neurological outcome at 30 days (CPC less than 2)
Key secondary outcomes
Survival outcome at 30 days
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
Adult patients with non-traumatic cardiac arrest who underwent TTM at 33-36 degrees Celsius
Key exclusion criteria
Patients were excluded if they were less than 18 years old, underwent TTM at less than 32 degree Celsius (moderate therapeutic hypothermia), required extracorporeal membrane oxygenation (ECMO), or can not live independently. Patients with any missing values of the variables needed for the calculation of rCAST and/or for adjustments in the analyses were also excluded (complete case analyses).
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mitsuaki |
| Middle name | |
| Last name | Nishikimi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Emergency and Critical Care
Zip code
4668560
Address
Tsurumai-cho 64, Syowa-ku, Nagoya, Aichi, Japan
TEL
+81-52-744-2659
m0528332626@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuaki |
| Middle name | |
| Last name | Nishikimi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Emergency and Critical Care
Zip code
4668560
Address
Tsurumai-cho 64, Syowa-ku, Nagoya, Aichi, Japan
TEL
+81-52-744-2659
Homepage URL
m0528332626@yahoo.co.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
agoya University Graduate School of 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 in Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu-sh, 292-8535, Chiba
Tel
0438-36-107
m0528332626@yahoo.co.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
| 2021 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
http://jaam-kanto.umin.ne.jp/sos_kanto.html
Publication of results
Unpublished
Result
URL related to results and publications
http://jaam-kanto.umin.ne.jp/sos_kanto.html
Number of participants that the trial has enrolled
259
Results
rCAST showed high predictive accuracy for the neurological outcome of PCAS patients who underwent TTM.
Results date posted
| 2023 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PCAS patients who underwent TTM
Participant flow
Among a total of565 patients with PCAS who underwent TTM, 259 were included.
Adverse events
none
Outcome measures
Neurological outcome at 30 days
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a part of SOS-KANTO 2017.
Management information
Registered date
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050164
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
