UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049523 |
|---|---|
| Receipt number | R000056394 |
| Scientific Title | the Japan Neurotrauma Data Bank Project 2023 |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/05/17 14:37:06 |
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Basic information
Public title
the Japan Neurotrauma Data Bank Project 2023
Acronym
the Japan Neurotrauma Data Bank Project 2023
Scientific Title
the Japan Neurotrauma Data Bank Project 2023
Scientific Title:Acronym
the Japan Neurotrauma Data Bank Project 2023
Region
| Japan |
Condition
Condition
severe traumatic brain injury
Classification by specialty
| Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is an epidemiological study of head injury in Japan.
Basic objectives2
Others
Basic objectives -Others
Epidemiological examination of age, sex, mechanism of injury, diagnosis, treatment method, and patient outcome of head injury cases. These results will be useful for the prevention of head injuries by disseminating them to society. So far, it has contributed to the reduction of head injuries caused by wearing seat belts and helmets. We will also examine the effects of treatment methods, and the results will be used as materials for the revision of the "Guidelines for Treatment and Management of Severe Head Injuries" published by the Japan Neurotrauma Society.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will investigate the frequency of head injury cases, including age, gender, mechanism of injury, diagnosis name, treatment, and outcome. We will also examine whether the content of treatment has an impact on outcomes.
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
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Glasgow Coma Scale (GCS) 8 or less at the time of admission, or head injury cases that worsened to GCS 8 or less during the course.
(2) A case of head injury that underwent neurosurgery.
Key exclusion criteria
(1) Chronic subdural hematoma
(2) Cases of cardiopulmonary arrest on arrival for which head injury was not the obvious cause
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Miyata |
Organization
Chiba Emergency Medical Center
Division name
Neurosurgery
Zip code
261-0012
Address
3-32-1 Isobe, Mihama Ward, Chiba City, Chiba Prefecture, Japan
TEL
043-279-2211
miyata-a@pluto.dti.ne.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Suehiro |
Organization
International University of Health and Welfare, School of Medicine
Division name
Neurosurgery
Zip code
286-8520
Address
852 Hatakeda Narita City, Chiba Prefecture, Japan
TEL
0476-35-5600
Homepage URL
esuehiro@iuhw.ac.jp
Sponsor or person
Institute
The Japan Society of Neurotraumatology
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Chiba District Ethics Review Committee
Address
852 Hatagada, Narita City, Chiba Prefecture
Tel
0476355600
mitsuhiro.hatakeyama@iuhw.ac.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
| 2023 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation item
Age, gender, mechanism of injury, diagnosis, treatment method, patient outcome
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056394
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
