UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040314 |
|---|---|
| Receipt number | R000045870 |
| Scientific Title | A study of outcomes and related factors after traumatic brain injury in the elderly |
| Date of disclosure of the study information | 2020/05/30 |
| Last modified on | 2020/05/03 10:10:51 |
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Basic information
Public title
A study of outcomes and related factors after traumatic brain injury in the elderly
Acronym
A study of outcomes and related factors after traumatic brain injury in the elderly
Scientific Title
A study of outcomes and related factors after traumatic brain injury in the elderly
Scientific Title:Acronym
A study of outcomes and related factors after traumatic brain injury in the elderly
Region
| Japan |
Condition
Condition
Traumatic brain injury
Classification by specialty
| Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the frequency of traumatic brain injury including traffic injuries for the elderly people, image diagnosis, outcomes, and degree of higher brain dysfunction in a database.
Basic objectives2
Others
Basic objectives -Others
By examining the effects of higher brain dysfunction, dementia and its effects on rehabilitation, and the outcomes of long-term follow-up, we will investigate the factors related to outcomes and take measures.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The factors which associated to cognitive impairment after mild traumatic brain injury. The following factors; age, sex, body mass index, the finding of head computed tomography on admission, the consciousness grade for Japan Coma Scale at admission and discharge, and the presence of hypertension, diabetes mellitus, heart disease, psychiatric disorder, malignancy, and stroke.
Key secondary outcomes
The cause of mild traumatic brain injury.
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were needed hospitalization because of mild traumatic brain injury
Key exclusion criteria
Patients with dementia before mild traumatic brain injury
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Fusao |
| Middle name | |
| Last name | Ikawa |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Neurosurgery
Zip code
693-8555
Address
4-1-1 Himebara, Izumo City, Shimane
TEL
0853-22-5111
fikawa-nsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | Fusao |
| Middle name | |
| Last name | Ikawa |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Neurosurgery
Zip code
693-8555
Address
4-1-1 Himebara, Izumo City, Shimane
TEL
0853-22-5111
Homepage URL
fikawa-nsu@umin.ac.jp
Sponsor or person
Institute
Shimane Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
no
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
Shimane Prefectural Central Hospital, Clinical Research and Trial Management Center
Address
4-1-1 Himebara, izumo, shimane
Tel
0853225111
chiken@spch.izumo.shimane.jp
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
| 2020 | Year | 05 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 1999 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 1999 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Under analysis and before open
Management information
Registered date
| 2020 | Year | 05 | Month | 06 | Day |
Last modified on
| 2020 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045870
