UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043483 |
|---|---|
| Receipt number | R000047652 |
| Scientific Title | the study for the relation of traumatic bone injury and trauma severity, organ injury in trauma patients |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2024/02/28 14:28:23 |
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Basic information
Public title
the study for the relation of traumatic bone injury and trauma severity, organ injury in trauma patients
Acronym
relation of traumatic bone injury and trauma severity, organ injury
Scientific Title
the study for the relation of traumatic bone injury and trauma severity, organ injury in trauma patients
Scientific Title:Acronym
relation of traumatic bone injury and trauma severity, organ injury
Region
| Japan |
Condition
Condition
trauma
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the relationship between bone fracture and internal organ injury by trauma.
Basic objectives2
Others
Basic objectives -Others
We aim to obtain knowledge about the association with bone fracture, organ injury, and severity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We analyze the relationships between rib fractures and trauma severity scores.
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
1. patients who visited to see a doctor in the emergency department, Gunma university hospital from Apr 1, 2015, to Mar 31, 2020.
2. patients who were taken image examination to diagnose
Key exclusion criteria
1. patients who were injured after developed internal diseases
2. cases which doctors thought inappropriate
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Oshima |
| Middle name | |
| Last name | Kiyohiro |
Organization
Graduate school of medicine
Division name
Emergency medicine
Zip code
371-8511
Address
Showa-machi 3-39-22, Maebashi-city, Gunma, Japan
TEL
027-220-8541
kiyohiro@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Fukushima |
| Middle name | |
| Last name | Kazunori |
Organization
Gunma University Graduate school of medicine
Division name
Emergency medicine
Zip code
371-8511
Address
Showa-machi 3-39-22, Maebashi-city, Gunma, Japan
TEL
027-220-8541
Homepage URL
m10201076@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Gunma University Hospital
Address
Showa-machi 3-39-15, Maebashi-city, Gunma, Japan
Tel
027-220-8740
None
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
| 2021 | Year | 03 | 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
1000
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
| 2020 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we extract patient's data from the electrical medical records.
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047652
