Trial Review

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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
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
Secondary ID [1] 313655 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burns 336236 0
Condition category
Condition code
Injuries and Accidents 332771 332771 0 0
Burns

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 330262 0
Diagnosis / Prognosis
Comparator / control treatment
no control group, observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340454 0
prealbumin
Timepoint [1] 340454 0
On admission, bloods taken within 24 hours, and on day 3.
Primary outcome [2] 340298 0
Circulating protein C level
Timepoint [2] 340298 0
On admission, bloods taken within 24 hours, and on day 3.
Primary outcome [3] 340453 0
procalitonin
Timepoint [3] 340453 0
On admission, bloods taken within 24 hours, and on day 3.
Secondary outcome [1] 444121 0
ICU length of stay
Timepoint [1] 444121 0
duration of hospital admission
Secondary outcome [2] 444122 0
total ventilated days
Timepoint [2] 444122 0
duration of hospital admission
Secondary outcome [3] 444119 0
total number of surgeries
Timepoint [3] 444119 0
duration of hospital admission
Secondary outcome [4] 444129 0
hospital/ventilator acquired pneumonia (HAP/VAP)
Timepoint [4] 444129 0
duration of hospital admission
Secondary outcome [5] 444124 0
sepsis
Timepoint [5] 444124 0
duration of hospital admission
Secondary outcome [6] 444118 0
mean daily intravenous fluids
Timepoint [6] 444118 0
over first 72hr of admission
Secondary outcome [7] 444123 0
total dialysed days
Timepoint [7] 444123 0
duration of hospital admission
Secondary outcome [8] 444131 0
mortality
Timepoint [8] 444131 0
duration of hospital admission
Secondary outcome [9] 444130 0
acute respiratory distress syndrome (ARDS)
Timepoint [9] 444130 0
duration of hospital admission
Secondary outcome [10] 444120 0
total length of stay
Timepoint [10] 444120 0
duration of hospital admission

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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who had local or systemic infections at time of injury, or had a preexisting coagulopathy (including conditions requiring anticoagulation medications).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/03/2022
Date of last participant enrolment
Anticipated
Actual
26/10/2023
Date of last data collection
Anticipated
Actual
9/01/2024
Sample size
Target
89
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27456 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 27455 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 43568 0
2139 - Concord
Recruitment postcode(s) [2] 43567 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 318121 0
Charities/Societies/Foundations
Name [1] 318121 0
Ramsay Research and Teaching Fund
Country [1] 318121 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320513 0
Individual
Name [1] 320513 0
Dr Ruilong Zhao - Sutton Research Laboratory, Kolling Institute of Medical Research
Address [1] 320513 0
Country [1] 320513 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316766 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316766 0
Ethics committee country [1] 316766 0
Australia
Date submitted for ethics approval [1] 316766 0
24/12/2020
Approval date [1] 316766 0
16/06/2021
Ethics approval number [1] 316766 0

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

Contacts
Principal investigator
Name 138950 0
Dr Ruilong Zhao
Address 138950 0
Sutton Research Laboratory, Kolling Institute of Medical Research, 10 Westbourne St, St Leonards NSW 2065
Country 138950 0
Australia
Phone 138950 0
+61414077506
Fax 138950 0
Email 138950 0
[email protected]
Contact person for public queries
Name 138951 0
Ruilong Zhao
Address 138951 0
Sutton Research Laboratory, Kolling Institute of Medical Research, 10 Westbourne St, St Leonards NSW 2065
Country 138951 0
Australia
Phone 138951 0
+61414077506
Fax 138951 0
Email 138951 0
[email protected]
Contact person for scientific queries
Name 138952 0
Ruilong Zhao
Address 138952 0
Sutton Research Laboratory, Kolling Institute of Medical Research, 10 Westbourne St, St Leonards NSW 2065
Country 138952 0
Australia
Phone 138952 0
+61414077506
Fax 138952 0
Email 138952 0
[email protected]

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.