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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011283
Receipt No. R000010774
Scientific Title Development and validation of clinical decision rules for cervical CT and MRI in trauma patients
Date of disclosure of the study information 2013/08/01
Last modified on 2016/01/29

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Basic information
Public title Development and validation of clinical decision rules for cervical CT and MRI in trauma patients
Acronym C-spine CDR study
Scientific Title Development and validation of clinical decision rules for cervical CT and MRI in trauma patients
Scientific Title:Acronym C-spine CDR study
Region
Japan

Condition
Condition cervical spine injury,
cervical spinal cord injury without bony injury
Classification by specialty
Orthopedics Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate a clinical decision rule for cervical CT in patients with trauma to the head or neck. To validate a clinical decision rule for cervical MRI in patients with suspected mild cervical spinal cord injury without bony injury.
Basic objectives2 Others
Basic objectives -Others To develop efficient clinical decision rules in order to avoid unnecessary radiological examinations without overlooking injuries.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To calculate sensitivity and specificity of the CT-CDR for detection of cervical spine injury in patients with trauma to the head or neck.
To calculate sensitivity and specificity of the MR-CDR for intramedullary lesion in patients with suspected mild cervical spinal cord injury without bony injury.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with trauma to the head or neck who are transported by ambulance
Key exclusion criteria patients with penetrating neck trauma
patients who are thought to be innappropriate by the attending physician
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Inagaki Takeshi
Organization National Center for Global Health and Medicine Hospital
Division name Emergency Department
Zip code
Address 1-21-1 Toyama Shinjuku Tokyo
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Inagaki Takeshi
Organization National Center for Global Health and Medicine Hospital
Division name Emergency Department
Zip code
Address 1-21-1 Toyama Shinjuku Tokyo
TEL 03-3202-7181
Homepage URL
Email tinagaki@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine Hospital
Institute
Department

Funding Source
Organization The Grant of National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Seirei Hamamatsu General Hospital
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

Other administrative information
Date of disclosure of the study information
2013 Year 08 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 Completed
Date of protocol fixation
2012 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observation
background data
date of injury, age, sex, alcohol intake, mechanism of injury
physical examination
consciousness level (Glasgow Coma Scale score), posterior cervical tenderness, neurological deficit (Frankel grade)
radiological examination
cervical CT, fracture, dislocation, OPLL
cervical MRI, intramedullary lesion on T2 weighted image, minimum diameter of spinal canal, spinal cord compression
follow up
cervical immobilization, cervical spine surgery, date of admission, duration of admission, discharge state, neurological outcome at discharge (Frankel grade)

Management information
Registered date
2013 Year 07 Month 26 Day
Last modified on
2016 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010774

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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