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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034672
Receipt No. R000039422
Official scientific title of the study analysis of mild traumatic brain injury patient's database
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/28

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Basic information
Official scientific title of the study analysis of mild traumatic brain injury patient's database
Title of the study (Brief title) analysis of mild traumatic brain injury patient's database
Region
Japan

Condition
Condition mild traumatic head injury
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the need of head CT in the mild head injury patient, rate of intracranial lesion, risk factor
Basic objectives2 Others
Basic objectives -Others assessment of treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skull fracture or intracranial lesion finding on admission
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the mild head injury patients who consulted outpatient of the Tokyo Women's Medical center east by July, 2017 from January, 2015, it is a person with the registration for a database
Key exclusion criteria none
Target sample size 2675

Research contact person
Name of lead principal investigator Hidetoshi Kasuya
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Neurosurgery
Address 2-1-10 nishiogu Arakawa-ku Tokyo,Japan
TEL 03-3810-1111
Email sobara@twmu.ac.jp

Public contact
Name of contact person Chika Yamada
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Neurosurgery
Address 2-1-10 nishiogu Arakawa-ku Tokyo,Japan
TEL 03-3810-1111
Homepage URL
Email c.yamada@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Medical Center East
Institute
Department

Funding Source
Organization Tokyo Women's Medical University Medical Center East
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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 Day

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 01 Day
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
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 none

Management information
Registered date
2018 Year 10 Month 28 Day
Last modified on
2018 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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