UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035160 |
|---|---|
| Receipt number | R000040074 |
| Scientific Title | 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 | 2018/12/06 |
| Last modified on | 2023/11/06 09:03:21 |
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Basic information
Public title
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
Acronym
Research on long-term changes and related factors for ruptured cerebral aneurysm
Scientific Title
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
Research on long-term changes and related factors for ruptured cerebral aneurysm
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage, ruptured cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk factors of ruptured cerebral aneurysm by the investigation for the change of size, site, age, gender difference, cerebral vasospasm / delayed cerebral ischemia, treatment method, and outcome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
modified Rankin scale at discharge, 6 month after onset
Key secondary outcomes
change of size, site, age, gender difference, cerebral vasospasm / delayed cerebral ischemia, treatment method for ruptured cerebral aneurysm
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
aneurysmal subarachnoid hemorrhage cases diagnosed by CT, MRI, or cerebrospinal fluid study, and subarachnoid hemorrhage cases caused by ruptured cerebral aneurysm confirmed by CT angiography, MR angiography, or digital subtraction angiography
Key exclusion criteria
unknown subarachnoid hemorrhage, subarachnoid hemorrhage without ruptured cerebral aneurysm, subarachnoid hemorrhage without any imaging study
Target sample size
2000
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,
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
693-8555
Address
4-1-1 Himebara, Izumo, Shimane
TEL
0853225111
Homepage URL
fikawa-nsu@umin.ac.jp
Sponsor or person
Institute
Shimane Prefectural Central Hospital
Department of Neurosurgery
4-1-1 Himebara, Izumo City, Shimane,
Institute
Department
Personal name
Funding Source
Organization
Shimane Prefectural Central Hospital
Department of Neurosurgery
4-1-1 Himebara, Izumo City, Shimane,
Organization
Division
Category of Funding Organization
Self funding
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, shimane
Tel
0853225111
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 06 | 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
2000
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under making paper
Management information
Registered date
| 2018 | Year | 12 | Month | 06 | 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=R000040074
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
