Skip to content

Validating protein C as a blood marker to predict outcomes in burns patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000141448
Enrollment
86
Registered
2025-02-07
Start date
2022-03-31
Completion date
2023-10-26
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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, IC

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

Sponsors

Northern Sydney Local Health District
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Those who had local or systemic infections at time of injury, or had a preexisting coagulopathy (including conditions requiring anticoagulation medications).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026