UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021149
Receipt number R000024397
Scientific Title Rebleeding of aneurysmal SAH before admission to the neurosurgical institution
Date of disclosure of the study information 2016/02/23
Last modified on 2017/03/29 12:37:57

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Basic information

Public title

Rebleeding of aneurysmal SAH before admission to the neurosurgical institution

Acronym

Rebleeding of aneurysmal SAH before admission to the neurosurgical institution

Scientific Title

Rebleeding of aneurysmal SAH before admission to the neurosurgical institution

Scientific Title:Acronym

Rebleeding of aneurysmal SAH before admission to the neurosurgical institution

Region

Japan


Condition

Condition

Aneurysmal subarachnoid hemorrhage

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the incidence and clinical features of aneurysmal SAH cases rebleeding before admission to the neurosurgical institution.

Basic objectives2

Others

Basic objectives -Others

field survey

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Glasgow outcome scale

Key secondary outcomes



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

The cases whose clinical histories before neurosurgical institution are fully obtained .

Key exclusion criteria

The cases whose clinical histories before neurosurgical institution are unclear .

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ogasawara yukari

Organization

Hirosaki university graduate school of medicine

Division name

Department of Neurosurgery

Zip code


Address

5 Zaifu-cho Hirosaki,036-8562 Japan

TEL

0172-39-5115

Email

oyukarin2271@icloud.com


Public contact

Name of contact person

1st name
Middle name
Last name Ogasawara Yukari

Organization

Hirosaki university graduate school of medicine

Division name

Department of Neurosurgery

Zip code


Address

5 Zaifu-cho Hirosaki,036-8562 Japan

TEL

0172-39-5115

Homepage URL


Email

oyukarin2271@icloud.com


Sponsor or person

Institute

Hirosaki university graduate school of medicine
Department of Neurosurgery

Institute

Department

Personal name



Funding Source

Organization

Hirosaki university graduate school of medicine
Department of Neurosurgery

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


Email



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 むつ病院 青森市民病院 青森労災病院


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 23 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

2014 Year 10 Month 22 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients:Cases with SAH admitted to our hospital
Subtype of patient:Cases whose clinical histories are
clear
Clinical parameters:Hunt and Hess grade,Fisher's classification, Glasgow Outcome Scale,etc


Management information

Registered date

2016 Year 02 Month 22 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=R000024397


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name