Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001464358
Ethics application status
Approved
Date submitted
12/10/2017
Date registered
16/10/2017
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Injuries from bicycle accidents presenting to an emergency department in NSW, Australia
Scientific title
Cause, type and severities of bicycle injuries amongst adult cyclists presenting to a NSW emergency department
Secondary ID [1] 292772 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Bicycle injuries study (BIS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bicycle injuries 304565 0
Condition category
Condition code
Injuries and Accidents 303891 303891 0 0
Fractures
Injuries and Accidents 303892 303892 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who sustain an injury as a result of an accident involving a bicycle will have data obtained from their medical record relating only to the crash circumstances, resulting injuries and treatment. As such, each participant is only to be observed once, with no further follow up.
Intervention code [1] 299004 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303481 0
Quantitative description of all injury types & causes.
Timepoint [1] 303481 0
On presentation to the emergency department
Secondary outcome [1] 339038 0
Assessment of the distribution of the major contributing factors to injury severity (on the part of motor vehicles, the cyclist, environmental & other/non-environmental circumstances)
Timepoint [1] 339038 0
On presentation to the emergency department

Eligibility
Key inclusion criteria
Patients are invited to participate if they meet all of the following criteria: aged 18 years or older; present to the emergency department at Royal North Shore Hospital (RNSH) in NSW in the trial recruitment period due to injuries following involvement in an accident caused by a bicycle, as either a rider or pedestrian; treating doctor has assessed them as being fit to provide medical consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following patients are to be excluded: under the age of 18 years of age; those not deemed fit to participate & give informed medical consent by their treating doctor; those who do not consent to participate

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
An excel expandable spread sheet will be used to capture and analyse the quantitative data relating to the numerical distribution of cycling-related injury cause, type and severity. The data collected will be collapsed into patterns to determine the contribution of cycling accident circumstances to the injury type or severity. The primary statistical tool for this pattern analysis will be excel, with any additional qualitative data analysed using nVivo.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/05/2017
Date of last participant enrolment
Anticipated
4/05/2019
Actual
Date of last data collection
Anticipated
4/05/2019
Actual
Sample size
Target
500
Accrual to date
144
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9094 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 17591 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 297402 0
Hospital
Name [1] 297402 0
Emergency Department, Royal North Shore Hospital
Country [1] 297402 0
Australia
Primary sponsor type
Hospital
Name
Emergency Department, Royal North Shore Hospital
Address
Reserve Road, ST LEONARDS NSW 2065
Country
Australia
Secondary sponsor category [1] 296392 0
None
Name [1] 296392 0
N/A
Address [1] 296392 0
N/A
Country [1] 296392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298508 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 298508 0
Ethics committee country [1] 298508 0
Australia
Date submitted for ethics approval [1] 298508 0
26/03/2017
Approval date [1] 298508 0
12/04/2017
Ethics approval number [1] 298508 0
LNR/17/HAWKE/70

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77298 0
Dr Mark Gillett
Address 77298 0
Emergency Department, Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country 77298 0
Australia
Phone 77298 0
+61 457 829 396
Fax 77298 0
Email 77298 0
mgillett@med.usyd.edu.au
Contact person for public queries
Name 77299 0
Mark Gillett
Address 77299 0
Emergency Department, Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country 77299 0
Australia
Phone 77299 0
+61 457 829 396
Fax 77299 0
Email 77299 0
mgillett@med.usyd.edu.au
Contact person for scientific queries
Name 77300 0
Mark Gillett
Address 77300 0
Emergency Department, Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country 77300 0
Australia
Phone 77300 0
+61 457 829 396
Fax 77300 0
Email 77300 0
mgillett@med.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.