UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016953 |
|---|---|
| Receipt number | R000019670 |
| Scientific Title | Atypical onset of aneurysmal subarachnoid hemorrhage |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2017/03/29 12:39:56 |
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Basic information
Public title
Atypical onset of aneurysmal subarachnoid hemorrhage
Acronym
Atypical onset of aneurysmal subarachnoid hemorrhage
Scientific Title
Atypical onset of aneurysmal subarachnoid hemorrhage
Scientific Title:Acronym
Atypical onset of aneurysmal subarachnoid hemorrhage
Region
| Japan |
Condition
Condition
aneurysmal subarachnoid hemmorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Initial symptom of aneurysmal SAH (subarachnoid hemorrhage )is widerly known as severe sudden headache. Coexistent symptom of SAH are nausea,
vomiting,dizziness and LOC.
But a few cases have been reported that any patients occasionally complain of no headache.
Such a onset as this is considered to be an atypical onset .
Although it is estimated that patients with atypical onset tend to be suffered from misdiagnosis,
actual circumstances of atypical onset cases is unknown.
Our purpose is to recognize of frequency and critical course at atypical onset.
Basic objectives2
Others
Basic objectives -Others
Our purpose is to recognize of frequency and critical course at atypical onset. Based on anamnesis and medical record,we collect and put data in order.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Glasgou outocome scale
Key secondary outcomes
Hunt and Hess grade,Fisher group,incidence of vasospasm
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)the patients who can explain situation and their symptoms from initial onset to admission
2)the patients who can be explained situation of onset by A third party
Key exclusion criteria
the cases whose situation of onset is unknown
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Ogasawara |
Organization
Hirosaki university graduate school of medicine
Division name
department of neurosurgery
Zip code
Address
5 zaihu-cho Hirosaki,036-8562 Japan
TEL
0172-39-5115
oyukarin2271@icloud.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukari Ogasawara |
Organization
Hirosaki university graduate school of medicine
Division name
department of neurosurgery
Zip code
Address
5 zaihu-cho Hirosaki,036-8562 Japan
TEL
0172-39-5115
Homepage URL
oyukarin2271@icloud.com
Sponsor or person
Institute
Hirosaki university graduate school of medicinedepartment of neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Hirosaki university
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
Address
Tel
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
弘前大学医学部附属病院 黒石病院 十和田市立中央病院 青森市民病院 むつ病院 青森労災病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | 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
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data is not investigated yet.
Management information
Registered date
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019670
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
