UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021328 |
|---|---|
| Receipt number | R000024587 |
| Scientific Title | The single center study to predict the need for Whole Body Computed Tomography(WBCT) in blunt trauma patients |
| Date of disclosure of the study information | 2016/03/04 |
| Last modified on | 2016/04/17 12:14:34 |
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Basic information
Public title
The single center study to predict the need for Whole Body Computed Tomography(WBCT) in blunt trauma patients
Acronym
The study to predict the need for Whole Body Computed Tomography(WBCT) in blunt trauma patients
Scientific Title
The single center study to predict the need for Whole Body Computed Tomography(WBCT) in blunt trauma patients
Scientific Title:Acronym
The study to predict the need for Whole Body Computed Tomography(WBCT) in blunt trauma patients
Region
| Japan |
Condition
Condition
Blunt trauma patients suspected of multiple injuries
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To derive a prediction score to detect multiple injuries in blunt trauma patients and allow pysicians to use WBCT more selectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the presence of multiple injuries defined as Injury Severity Score>=16 in no less than 2 body regions found in WBCT.
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
| 15 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All multiple injury suspected blunt trauma patients
Key exclusion criteria
Patients who were transferred from other facilities and patients with incomplete medical records were excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimura Akio |
Organization
National Center for Global Health and Medicine
Division name
Emergency medicine
Zip code
Address
1-21-1Toyama Shinjyuku-ku Tokyo Japan
TEL
03-3202-7181
odahiro916@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Oda Hiroko |
Organization
National Center for Global Health and Medicine
Division name
Emergency Medicine
Zip code
Address
1-21-1Toyama Shinjyuku-ku Tokyo Japan
TEL
0332027181
Homepage URL
odahiro916@yahoo.co.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
国立国際医療研究センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 04 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 03 | Day |
Other
Other related information
We established a prediction rule based on cohort study.
All blunt patients who came to our emergency department ambulatory between 2011/6-2013/3 were enrolled.
Patients data: age,sex,mechanism of injury,vital signs,laboratory exams(CBC,coagulation study,biochemical examination) and radiology(Chest/pelvis Xray and Whole Body CT) examination were performed and each data were colllected from the medical record.
Variables potentially affecting the presentation of multiple injuries were idetified by bivariate analysis. Variables were confirmed by multivariate logistic regression,and a score was assigned based on the corresponding beta coefficient.
Prospective study was conducted to validate the prediction score.
Management information
Registered date
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2016 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024587
| 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 |
