UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051978 |
|---|---|
| Receipt number | R000059322 |
| Scientific Title | A Multicenter Prospective Study of the Effect of Alcohol Consumption on Severity in Traffic Trauma Caused by Bicyclists |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/08/22 21:02:18 |
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Basic information
Public title
Bicycle Injuries associated with ethanol intaKE study
Acronym
BIKE Study
Scientific Title
A Multicenter Prospective Study of the Effect of Alcohol Consumption on Severity in Traffic Trauma Caused by Bicyclists
Scientific Title:Acronym
BIKE study
Region
| Japan |
Condition
Condition
Traffic Accidents Encountered by Adults While Riding a Bicycle
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This multicenter prospective study will be conducted in Japan to examine the effect of alcohol consumption on severity of injury in adults presenting to the emergency department with traffic injuries caused by bicycling.
Basic objectives2
Others
Basic objectives -Others
We will clarify the actual situation of drunk driving in bicycle accidents. In addition, we aim to develop new knowledge by examining the effects of alcohol consumption on the severity of injuries and medical economic aspects of bicycle accidents, such as time spent in the emergency room and medical expenses incurred during emergency visits.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In-hospital death or surgery within 24 hours of arrival, trauma of ISS 16 or more
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Trauma patients over 20 years of age who were transported to the emergency room for bicycle accidents
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiraku |
| Middle name | |
| Last name | Funakoshi |
Organization
Tokyobay Urayasu Ichikawa Medical Center
Division name
Emergency and Critical Care Medicine
Zip code
2740001
Address
3-4-32, Todaijima, Urayasu
TEL
+81-473513101
hirakufunakoshi@gmail.com
Public contact
Name of contact person
| 1st name | Hiraku |
| Middle name | |
| Last name | Funakoshi |
Organization
Tokyobay Urayasu Ichikawa Medical Center
Division name
Emergency and Critical Care Medicine
Zip code
2790001
Address
3-4-32, Todaijima, Urayasu
TEL
+81-473513101
Homepage URL
hirakufunakoshi@gmail.com
Sponsor or person
Institute
Tokyobay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
ZENKYOREN(National Mutual Insurance Federatoin of Agricultural Cooperatives)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyobay Urayasu Ichikawa Medical Center
Address
3-4-32, Todaijima, Urayasu
Tel
+81-47351310
hirakufunakoshi@gmail.com
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 | 09 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although the Road Traffic Law regulates the riding of bicycles while intoxicated, the dangers are less well known than for driving cars and motorcycles. As a result, the exact reality of drunk driving on bicycles is not yet known, and research on the effects of alcohol consumption on the severity of bicycle accidents is still scarce. This multicenter prospective study is expected to contribute to policy making by educating the public about the dangers of bicycling while intoxicated, and even considering stricter penalties.
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059322
