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Trial registered on ANZCTR
Registration number
ACTRN12619001026112
Ethics application status
Approved
Date submitted
10/05/2019
Date registered
18/07/2019
Date last updated
25/01/2022
Date data sharing statement initially provided
18/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Randomised controlled trial of an integrated securement device or tissue adhesive versus standard care (bordered polyurethane) dressings on peripheral intravenous cannula failure in paediatric patients.
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Scientific title
Paediatric Reduction in Emergency Cannula Accidental REmoval (PRECARE) Trial: Randomised controlled trial of an integrated securement device or tissue adhesive versus standard care (bordered polyurethane) dressings on peripheral intravenous cannula failure in paediatric patients.
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Secondary ID [1]
298021
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Nil
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Universal Trial Number (UTN)
U1111-1232-0316
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Trial acronym
PRECARE Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral IntraVenous Cannula failure prior to completion of therapy
312473
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Condition category
Condition code
Public Health
311020
311020
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0
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Health service research
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Emergency medicine
311336
311336
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0
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Other emergency care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants in this study will have a Peripheral Intravenous Cannula (PIVC) inserted in the emergency department by paediatric specialised Doctors and Nurses. Consented patients will have their PIVC dressed and secured with one of the three following randomly assigned options:
1) Standard care (CONTROL): Bordered polyurethane dressing (BPU) (Tegaderm Advanced®; 3M) – standard care most commonly used at Logan and Ipswich hospital Emergency Department
2) Advanced dressing: SorbaView SHIELD® (Centurion Medical Products)
3) Advanced dressing with tissue adhesive: SorbaView SHIELD® (Centurion Medical Products) and Tissue Adhesive (SecurePortIVâ„¢ (Adhezion Biomedical®)
Patients will be monitored daily for a maximum of 4 weeks to ensure protocol adherence and assess for any complications. The randomly allocated dressing will be applied from device insertion and changed as clinically indicated until removal of the PIVC.
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Intervention code [1]
314250
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Prevention
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Intervention code [2]
314251
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Treatment: Devices
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Comparator / control treatment
Control group patients will receive standard care (defined as most common practice among clinicians at Logan and Ipswich hospital Emergency Departments). Standard care is defined as a Bordered polyurethane dressing (BPU) (Tegaderm Advanced®; 3M) applied to secure a PIVC insertion until device removal.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary aim of this study is to test PIVC failure: composite of any unplanned PIVC removal, where reinsertion is required. This includes complete dislodgement, infection, occlusion (PIVC cannot be flushed, or leakage occurs when fluid infused), infiltration (fluid perfusion into the surrounding tissue), phlebitis (2 or more of pain, redness, swelling). A composite measure, that will increase trial precision and efficiency, was chosen since PIVC failure is the outcome of importance to patients, with poor securement leading to the same endpoint. This will be measured through iEMR records, FLACC and FACES pain tool and documented nursing observations.
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Assessment method [1]
319815
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Timepoint [1]
319815
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On removal of the PIVC as decided by the treating doctor as no longer required for up to 4 weeks or at the time of loss of PIVC from complications such as accidental removal or occlusion (as appropriate).
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Secondary outcome [1]
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As a composite secondary outcome, PIVC complications: as defined previously (dislodgement, occlusion, infiltration, infection, phlebitis) will all be treated as one. An analysis of the individual causes of PIVC complications will also be examined by review of medical records, Pain face and numeric rating scales, and documented paediatric specific staff observations.
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Assessment method [1]
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Timepoint [1]
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Whilst the PIVC is in-situ and on device removal
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Secondary outcome [2]
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PIVC longevity: time from PIVC insertion to removal due to completion of treatment or complication that will be measured by the cannula log used on iEMR electronic patient records.
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Assessment method [2]
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Timepoint [2]
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On removal of the PIVC as decided by the treating doctor as no longer required or at the time of loss of PIVC from complications such as accidental removal or occlusion (as appropriate).
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Secondary outcome [3]
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Pain and distress: associated with PIVC and dressing removal, measured using validated FLACC and Wong - baker FACES scales appropriate to patient age and development.
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Assessment method [3]
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Timepoint [3]
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Observations will be documented whilst the PIVC is in-situ looking for signs of pain and distress and on device removal a final pain and distress score will be documented.
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Secondary outcome [4]
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Healthcare costs will be measured by mapping the resource pathways through estimating costs for the staff time and equipment associated with insertion, management, removal and complications during PIVC treatment. This will be assessed via cost data linkage to medical records.
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Assessment method [4]
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Timepoint [4]
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All participants will cease trial participation at PIVC removal.
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Secondary outcome [5]
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Staff satisfaction: measured on a scale of 0 (min.) to 10 (max.)
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Assessment method [5]
369595
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Timepoint [5]
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On device removal.
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Eligibility
Key inclusion criteria
• Aged greater than 6 months to 8 years inclusive
• Anticipated requirement for a PIVC for more than 24hours
• Hospital admission to the inpatient unit requiring an expected stay of 24 hours or more
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Minimum age
6
Months
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Maximum age
8
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Known allergy to study products
• Non-English-speaking family without interpreters
• Has a currently identified blood stream infection
• Current skin tear or at high risk of tear
• Previous participation in the study
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting to ED and requiring insertion of PIVC will be screened by research nurses (ReN) and trained clinicians (research champions) for eligibility, using pre-determined inclusion / exclusion criteria. ReN and research champions will discuss suitability with the managing clinician and PIVC inserter, prior to approaching family for informed consent. Written informed consent by an appropriate legal guardian will be obtained prior to intervention, at time of enrolment. Due to workflow pressures, allocation concealment will be maintained through sequentially numbered, sealed, opaque envelopes, provided to sites and indicate the allocated treatment arm upon opening. This procedure will be regularly audited by the ReN and CIA. It is not possible to blind the intervention or outcome assessors. The dressings must be monitored by clinical staff and they are visibly different. The statistician undertaking the data analysis will be blinded to study group
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer based randomisation will be used to allocate patients in a 1:1:1 ratio with randomly varied block sizes stratified by hospital (Logan vs Ipswich). ReN or clinician will select the lowest numbered study pack (next pack system) from study baskets in each ED. .
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Not Applicable
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Cleaned and de-identified study observations will be transferred to Stata 15 for data management and analysis by AI Mihala. Participant and clinical characteristics, including outcomes will be presented in tables using descriptive statistics, appropriate to data characteristics. Chi-squared statistics will be used to compare the incidence of outcomes between study groups. Incidence Rates will be calculated using the total dwell times by groups. Kaplan-Meier curve will display survival (of PIVCs) over time by study groups. The relative risk (hazard ratio, HR) of failure will be computed with Cox regression; confounding by and interaction with patient/clinical characteristics will be investigated during multivariable Cox regression model building. Age may be entered into the models as continuous or categorical (age groups, i.e. less than or equal to 12 months old) variable, depending on univariable results. Missing values will not be imputed. Results will be evaluated using clinical and statistical significance (p less than or equal to 0.025 one-sided). No interim analysis will be performed.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
19/08/2019
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Actual
11/02/2020
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Date of last participant enrolment
Anticipated
1/06/2022
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Actual
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Date of last data collection
Anticipated
30/06/2022
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Actual
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Sample size
Target
506
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Accrual to date
390
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
13642
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Logan Hospital - Meadowbrook
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Recruitment hospital [2]
13643
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Ipswich Hospital - Ipswich
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Recruitment postcode(s) [1]
26314
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4131 - Meadowbrook
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Recruitment postcode(s) [2]
26315
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4305 - Ipswich
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Funding & Sponsors
Funding source category [1]
302546
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Charities/Societies/Foundations
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Name [1]
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Emergency Medicine Foudation
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Address [1]
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Suite 1b, Terraces,
19 Lang Parade
Milton QLD 4064
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Country [1]
302546
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Logan Hospital Metro South HHS
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Address [1]
302455
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Cnr Loganlea and Armstrong Rd
Meadowbrook QLD 4131
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Country [1]
302455
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303191
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Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
303191
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Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane, QLD, 4101
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Ethics committee country [1]
303191
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Australia
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Date submitted for ethics approval [1]
303191
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08/01/2019
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Approval date [1]
303191
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27/03/2019
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Ethics approval number [1]
303191
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HREC/2019/QCHQ/45567
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Ethics committee name [2]
303192
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Griffith University Human Research Ethics Committee
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Ethics committee address [2]
303192
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Office for Research
Bray Centre, Nathan Campus
Nathan, QLD, 4111
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Ethics committee country [2]
303192
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Australia
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Date submitted for ethics approval [2]
303192
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04/04/2019
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Approval date [2]
303192
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15/04/2019
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Ethics approval number [2]
303192
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2019/284
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Ethics committee name [3]
303193
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University of Southern Queensland Human Research Ethics Committee
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Ethics committee address [3]
303193
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University of Southern Queensland, Ipswich Campus,
11 Salisbury Rd,
Ipswich QLD 4305
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Ethics committee country [3]
303193
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Australia
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Date submitted for ethics approval [3]
303193
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Approval date [3]
303193
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Ethics approval number [3]
303193
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Summary
Brief summary
There is a 25% failure rate for peripheral intravenous catheters (PIVC) inserted for infants and children requiring treatment within the emergency department and during hospitalisation. Our trial aims to test if new advances in catheter securement, medical grade superglue and an integrated dressing securement product are effective at preventing cannula failure and complications in paediatric patients. The outcome we are measuring is the decrease in failure rate between standard treatment and our new securement devices.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Brooke Charters
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Address
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Logan Hospital
Emergency Department
Cnr Loganlea and Armstrong Rds
Meadowbrook, QLD 4131
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Country
92806
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Australia
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Phone
92806
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+61 07 32998899
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Fax
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Email
92806
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[email protected]
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Contact person for public queries
Name
92807
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Ms Brooke Charters
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Address
92807
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Logan Hospital
Emergency Department
Cnr Loganlea and Armstrong Rds
Meadowbrook, QLD 4131
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Country
92807
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Australia
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Phone
92807
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+61 07 32998899
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Fax
92807
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Email
92807
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[email protected]
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Contact person for scientific queries
Name
92808
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Ms Brooke Charters
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Address
92808
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Logan Hospital
Emergency Department
Cnr Loganlea and Armstrong Rds
Meadowbrook, QLD 4131
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Country
92808
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Australia
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Phone
92808
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+61 07 32998899
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Fax
92808
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Email
92808
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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