UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034672 |
|---|---|
| Receipt number | R000039422 |
| Scientific Title | 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 15:12:35 |
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Basic information
Public title
analysis of mild traumatic brain injury patient's database
Acronym
analysis of mild traumatic brain injury patient's database
Scientific Title
analysis of mild traumatic brain injury patient's database
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Kasuya |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Neurosurgery
Zip code
Address
2-1-10 nishiogu Arakawa-ku Tokyo,Japan
TEL
03-3810-1111
sobara@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chika Yamada |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Neurosurgery
Zip code
Address
2-1-10 nishiogu Arakawa-ku Tokyo,Japan
TEL
03-3810-1111
Homepage URL
c.yamada@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Medical Center East
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039422
