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Trial registered on ANZCTR
Registration number
ACTRN12625000141448
Ethics application status
Approved
Date submitted
13/01/2025
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Validating protein C as a blood marker to predict outcomes in burns patients
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Scientific title
External validation of the "Skin and Circulating Activated protein C Levels Determining increased support in patients with severe burns" (SCALD) study to use circulating protein C to predict clinical outcomes in burns patients
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Secondary ID [1]
313655
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
burns
336236
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Condition category
Condition code
Injuries and Accidents
332771
332771
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0
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Burns
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participation involves blood collection at 2x timepoints (day 0 and 3), data collection from medical records.
Blood samples were measured for protein C, C-reactive protein, procalcitonin, prealbumin, and neutrophils.
Injury severity metrics were measured - burn size % total body surface area (TBSA), predominant burn depth, presence of an inhalational injury.
Treatment related outcomes were measured - mean daily intravenous fluid in the first 72hr, number of surgeries, total length of stay, ICU length of stay, number of ventilated or dialysed days.
Complication related outcomes were measured - sepsis, hospital/ventilator-acquired pneumonia (HAP/VAP), sepsis, acute respiratory distress syndrome (ARDS). mortality.
Patients were followed for the duration of their admission.
Due to some delays during Covid and lower than expected recruitment numbers over the past year, we included retrospectively collected data from Oct 2019 to June 2020 when the burns department was collecting admission protein C levels for all patients. This comprises a series of 19 patients. The total patients are pooled together rather than comprise two cohorts for comparison.
This study references a previous SCALD study - results published as below:
Lang, T. C., Zhao, R., et al. (2019) Plasma protein C levels are directly associated with better outcomes in patients with severe burns. Burns
Zhao, R., et al. (2021) Early protein C activation is reflective of burn injury severity and plays a critical role in inflammatory burden and patient outcomes. Burns
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Intervention code [1]
330262
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Diagnosis / Prognosis
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Comparator / control treatment
no control group, observational study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340454
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prealbumin
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Assessment method [1]
340454
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hospital pathology laboratory
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Timepoint [1]
340454
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On admission, bloods taken within 24 hours, and on day 3.
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Primary outcome [2]
340298
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Circulating protein C level
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Assessment method [2]
340298
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Protein C was measured by the hospitals' pathology laboratory.
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Timepoint [2]
340298
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On admission, bloods taken within 24 hours, and on day 3.
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Primary outcome [3]
340453
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procalitonin
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Assessment method [3]
340453
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hospital pathology laboratory
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Timepoint [3]
340453
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On admission, bloods taken within 24 hours, and on day 3.
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Secondary outcome [1]
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ICU length of stay
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Assessment method [1]
444121
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medical records
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Timepoint [1]
444121
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duration of hospital admission
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Secondary outcome [2]
444122
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total ventilated days
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Assessment method [2]
444122
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medical records
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Timepoint [2]
444122
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duration of hospital admission
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Secondary outcome [3]
444119
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total number of surgeries
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Assessment method [3]
444119
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medical records
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Timepoint [3]
444119
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duration of hospital admission
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Secondary outcome [4]
444129
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hospital/ventilator acquired pneumonia (HAP/VAP)
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Assessment method [4]
444129
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medical records
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Timepoint [4]
444129
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duration of hospital admission
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Secondary outcome [5]
444124
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sepsis
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Assessment method [5]
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medical records, Sepsis-3 Criteria
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Timepoint [5]
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duration of hospital admission
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Secondary outcome [6]
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mean daily intravenous fluids
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Assessment method [6]
444118
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medical records
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Timepoint [6]
444118
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over first 72hr of admission
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Secondary outcome [7]
444123
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total dialysed days
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Assessment method [7]
444123
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medical records
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Timepoint [7]
444123
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duration of hospital admission
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Secondary outcome [8]
444131
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mortality
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Assessment method [8]
444131
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medical records
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Timepoint [8]
444131
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duration of hospital admission
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Secondary outcome [9]
444130
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acute respiratory distress syndrome (ARDS)
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Assessment method [9]
444130
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medical records
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Timepoint [9]
444130
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duration of hospital admission
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Secondary outcome [10]
444120
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total length of stay
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Assessment method [10]
444120
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medical records
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Timepoint [10]
444120
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duration of hospital admission
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Eligibility
Key inclusion criteria
Consecutive patients admitted to Royal North Shore Hospital or Concord Repatriation General Hospital burns units with burns greater than 10%TBSA that were partial or full thickness between March 2022 and October 2023. A further retrospective cohort between Oct 2019 and June 2020 was also included for pooled analysis.
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Minimum age
16
Years
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Maximum age
No limit
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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
Those who had local or systemic infections at time of injury, or had a preexisting coagulopathy (including conditions requiring anticoagulation medications).
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
The IBM® SPSS® Statistics v20 package was used. Baseline demographics were analysed using descriptive statistics. Spearman’s correlation was conducted between burn size and the measured biomarkers. Independent-samples Mann-Whitney U tests were used to test for differences in biomarkers within burn depth, and the presence of an inhalational injury. Linear regression was used for continuous outcomes, and binomial logistic regression was used for dichotomous outcomes. Significant variables from univariate regressions and those with clinical plausibility were entered stepwise for multivariate regression modelling. Optimal models were judged by their percentage accuracy in classification. The discriminatory power of logistic regression models was assessed by area under the receiver-operator characteristic curve (AUROC). To aid in its potential clinical utility, the ROC curves were used to determine optimal cut-off points for PC that maximised Youden’s index
. False discovery rate was adjusted by the Benjamin-Hochberg procedure for primary outcomes relating to protein C.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
31/03/2022
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Date of last participant enrolment
Anticipated
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Actual
26/10/2023
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Date of last data collection
Anticipated
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Actual
9/01/2024
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Sample size
Target
89
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Accrual to date
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Final
86
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
27456
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Concord Repatriation Hospital - Concord
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Recruitment hospital [2]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
43568
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2139 - Concord
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Recruitment postcode(s) [2]
43567
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2065 - St Leonards
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Funding & Sponsors
Funding source category [1]
318121
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Charities/Societies/Foundations
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Name [1]
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Ramsay Research and Teaching Fund
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Address [1]
318121
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Country [1]
318121
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Australia
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Primary sponsor type
Government body
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Name
Northern Sydney Local Health District
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Address
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Country
Australia
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Secondary sponsor category [1]
320513
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Individual
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Name [1]
320513
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Dr Ruilong Zhao - Sutton Research Laboratory, Kolling Institute of Medical Research
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Address [1]
320513
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Country [1]
320513
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316766
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Northern Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
316766
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https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx
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Ethics committee country [1]
316766
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Australia
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Date submitted for ethics approval [1]
316766
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24/12/2020
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Approval date [1]
316766
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16/06/2021
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Ethics approval number [1]
316766
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Summary
Brief summary
We previously found that an blood marker called protein C can be measured on admission in burns patients at one hospital to provide information on their injury severity and predict outcomes. This study aims to verify these results still hold true in a new cohort of patients at two hospitals. Additionally the study aims to find if a simple cutoff value can be utilised to incorporate this marker into clinical practice to predict for important complications including sepsis, pneumonia, and death. This study references a previous SCALD study - results published as below: Lang, T. C., Zhao, R., et al. (2019) Plasma protein C levels are directly associated with better outcomes in patients with severe burns. Burns Zhao, R., et al. (2021) Early protein C activation is reflective of burn injury severity and plays a critical role in inflammatory burden and patient outcomes. Burns
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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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Dr Ruilong Zhao
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Address
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Sutton Research Laboratory, Kolling Institute of Medical Research, 10 Westbourne St, St Leonards NSW 2065
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Country
138950
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Australia
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Phone
138950
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+61414077506
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Fax
138950
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Email
138950
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[email protected]
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Contact person for public queries
Name
138951
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Ruilong Zhao
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Address
138951
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Sutton Research Laboratory, Kolling Institute of Medical Research, 10 Westbourne St, St Leonards NSW 2065
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Country
138951
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Australia
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Phone
138951
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+61414077506
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Fax
138951
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Email
138951
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[email protected]
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Contact person for scientific queries
Name
138952
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Ruilong Zhao
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Address
138952
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Sutton Research Laboratory, Kolling Institute of Medical Research, 10 Westbourne St, St Leonards NSW 2065
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Country
138952
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Australia
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Phone
138952
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+61414077506
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Fax
138952
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Email
138952
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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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