UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046282 |
|---|---|
| Receipt number | R000052809 |
| Scientific Title | Study for subarachnoid hemorrhage from The Japanese Standard Stroke Registry and multicenter registry; Study of long-term changes and related factors for size, site, age, gender difference of ruptured cerebral aneurysm, cerebral vasospasm / delayed cerebral ischemia, outcome, and treatment method |
| Date of disclosure of the study information | 2021/12/04 |
| Last modified on | 2023/11/06 09:05:25 |
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Basic information
Public title
Predict for Outcome Study of Aneurysmal SubArachnoid Hemorrhage from The Japanese Standard Stroke Registry andthe multicenter registry
Acronym
Predict for Outcome STudy of aneurysmal SubArachnoid Hemorrhage (POST.SAH)
Scientific Title
Study for subarachnoid hemorrhage from The Japanese Standard Stroke Registry and multicenter registry; Study of long-term changes and related factors for size, site, age, gender difference of ruptured cerebral aneurysm, cerebral vasospasm / delayed cerebral ischemia, outcome, and treatment method
Scientific Title:Acronym
Predict for Outcome STudy of aneurysmal SubArachnoid Hemorrhage (POST.SAH)
Region
| Japan |
Condition
Condition
Aneurysmal subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To predict the outcome of ruptured cerebral aneurysms in the Stroke Data Bank and multicenter data. We will also examine factors associated with aneurysm size, location, age, sex, treatment, and long-term change.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
modified Rankin Scale score at discharge
Key secondary outcomes
mortality, complication at discharge
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A patient who was diagnosed with subarachnoid hemorrhage by CT, MRI or cerebrospinal fluid examination at admission, and confirmed cerebral aneurysm by CTA, MRA, DSA imaging.
Key exclusion criteria
Cases of subarachnoid hemorrhage but no cerebral aneurysm was found, non-cerebral aneurysm
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | FUSAO |
| Middle name | |
| Last name | IKAWA |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Neurosurgery
Zip code
693-8555
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
TEL
0853-22-5111
fikawa-nsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | FUSAO |
| Middle name | |
| Last name | IKAWA |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Neurosurgery
Zip code
734
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
TEL
0822575227
Homepage URL
fik_1961@yahoo.co.jp
Sponsor or person
Institute
Shimane Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation Japan 2019, and Japan Society for the Promotion of Science, Grant-in-Aid for Scientific Research (C) 17K10829.
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
Shimane Prefectural Central Hospital, Clinical Research and Trial Management Center
Address
4-1-1 Himebara, Izumo City, Shimane, Japan
Tel
0853-22-5111
chiken@spch.izumo.shimane.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
島根県立中央病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 04 | 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 | 04 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subanalysis
Management information
Registered date
| 2021 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052809
