UMIN-CTR Clinical Trial

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
Email	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
Email	fikawa-nsu@umin.ac.jp

Sponsor
Institute	Shimane Prefectural Central Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045870