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Recruitment status Completed
Unique ID issued by UMIN UMIN000021328
Receipt No. 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

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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
Email 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
Email odahiro916@yahoo.co.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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