UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011283 |
|---|---|
| Receipt number | 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 13:23:52 |
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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
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
tinagaki@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010774
