UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Atypical onset of aneurysmal subarachnoid hemorrhage
Title of the study (Brief title)	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	Yukari Ogasawara
Organization	Hirosaki university graduate school of medicine
Division name	department of neurosurgery
Address	5 zaihu-cho Hirosaki,036-8562 Japan
TEL	0172-39-5115
Email	oyukarin2271@icloud.com

Public contact
Name of contact person	Yukari Ogasawara
Organization	Hirosaki university graduate school of medicine
Division name	department of neurosurgery
Address	5 zaihu-cho Hirosaki,036-8562 Japan
TEL	0172-39-5115
Homepage URL
Email	oyukarin2271@icloud.com

Sponsor
Institute	Hirosaki university graduate school of medicinedepartment of neurosurgery
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2009 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019670