Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001202550
Ethics application status
Approved
Date submitted
18/09/2024
Date registered
1/10/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
1/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Outcomes following Acute Shock in Trauma - The Sydney COAST Study
Scientific title
Prospective observational study assessing patient characteristics, clinical management, and short-term outcomes of major trauma patients with prehospital shock and hypotension.
Secondary ID [1] 313000 0
None.
Universal Trial Number (UTN)
Trial acronym
Sydney COAST Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 335190 0
Haemorrhage 335191 0
Shock 335192 0
Traumatic brain injury 335193 0
Condition category
Condition code
Emergency medicine 331681 331681 0 0
Resuscitation
Injuries and Accidents 331682 331682 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
Prehospital patients with major trauma induced shock treated by specialist prehospital medical teams (critical care physician and paramedic) will undergo usual (contemporary) treatment as directed by the treating physician.

There is no direct involvement for patients in this study as the entirety of their clinical care (and short term outcomes) are being directly observed. Clinical data (routinely collected data via medical records) will be collected over the first 30-days following injury
Intervention code [1] 329543 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339405 0
Mortality
Timepoint [1] 339405 0
Four hours (post injury)
Secondary outcome [1] 439801 0
Mortality
Timepoint [1] 439801 0
24-hours (post-injury)
Secondary outcome [2] 439802 0
Mortality
Timepoint [2] 439802 0
30-days (post-injury)
Secondary outcome [3] 439803 0
Prevalence of brain-injury associated shock
Timepoint [3] 439803 0
One week (post injury)
Secondary outcome [4] 439804 0
Prevalence of "Code Crimson" activations
Timepoint [4] 439804 0
One week (post injury)
Secondary outcome [5] 439805 0
Proportion of "Code Crimson" patients requiring interventional haemorrhage control procedures
Timepoint [5] 439805 0
One week (post-injury)
Secondary outcome [6] 439806 0
Prevalence of prehospital "massive transfusion"
Timepoint [6] 439806 0
One week (post-injury)
Secondary outcome [7] 439807 0
Incidence of acute traumatic coagulopathy
Timepoint [7] 439807 0
24 hours post injury

Eligibility
Key inclusion criteria
- Traumatic injury
- Treated by NSWA-AO prehospital medical teams from Sydney, Wollongong, or Orange bases.
- Age greater than or equal to 16 years
- Shock (defined below)
- Taken directly from scene to participating Sydney-based Major Trauma Centre.

Acute shock:
Any of the following;
- SBP less than 100mmHg at any time during prehospital care
- Shock Index >1 at any time during prehospital care
- Blood transfusion (packed red blood cells or plasma)
- Administration of inotropic agent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil specific

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to describe the dataset. Normally distributed outcomes will be reported as mean plus or minus standard deviation, whilst non-normal data will be reported as median and interquartile range. Categorical data will be reported as counts and proportions. Ninety-five per cent confidence intervals will be constructed around all point estimates.

Exploratory multivariable regression and prediction modelling will be utilised to investigate which prehospital or early, in-hospital variables may be associated with early mortality in this cohort.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
1/02/2030
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317439 0
Government body
Name [1] 317439 0
NSW Health
Country [1] 317439 0
Australia
Primary sponsor type
Government body
Name
NSW Health
Address
Country
Australia
Secondary sponsor category [1] 319732 0
None
Name [1] 319732 0
None
Address [1] 319732 0
Country [1] 319732 0
Other collaborator category [1] 283199 0
Hospital
Name [1] 283199 0
Liverpool Hospital
Address [1] 283199 0
Country [1] 283199 0
Australia
Other collaborator category [2] 283200 0
Hospital
Name [2] 283200 0
St George Hospital
Address [2] 283200 0
Country [2] 283200 0
Australia
Other collaborator category [3] 283201 0
Hospital
Name [3] 283201 0
Royal Prince Alfred Hospital
Address [3] 283201 0
Country [3] 283201 0
Australia
Other collaborator category [4] 283202 0
Hospital
Name [4] 283202 0
St Vincent's Hospital
Address [4] 283202 0
Country [4] 283202 0
Australia
Other collaborator category [5] 283203 0
Hospital
Name [5] 283203 0
Westmead Hospital
Address [5] 283203 0
Country [5] 283203 0
Australia
Other collaborator category [6] 283249 0
Hospital
Name [6] 283249 0
Royal North Shore Hospital
Address [6] 283249 0
Country [6] 283249 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316157 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316157 0
Ethics committee country [1] 316157 0
Australia
Date submitted for ethics approval [1] 316157 0
21/05/2024
Approval date [1] 316157 0
09/07/2024
Ethics approval number [1] 316157 0
2024/ETH01020

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

Contacts
Principal investigator
Name 136970 0
Dr Christopher Partyka
Address 136970 0
NSW Ambulance (Aeromedical Operations) 33 Nancy Ellis Leebold Drive, Bankstown Aerodrome NSW 2200
Country 136970 0
Australia
Phone 136970 0
+61 410585798
Fax 136970 0
Email 136970 0
Christopher.Partyka@health.nsw.gov.au
Contact person for public queries
Name 136971 0
Christopher Partyka
Address 136971 0
NSW Ambulance (Aeromedical Operations) 33 Nancy Ellis Leebold Drive, Bankstown Aerodrome NSW 2200
Country 136971 0
Australia
Phone 136971 0
+61 410585798
Fax 136971 0
Email 136971 0
Christopher.Partyka@health.nsw.gov.au
Contact person for scientific queries
Name 136972 0
Christopher Partyka
Address 136972 0
NSW Ambulance (Aeromedical Operations) 33 Nancy Ellis Leebold Drive, Bankstown Aerodrome NSW 2200
Country 136972 0
Australia
Phone 136972 0
+61 410585798
Fax 136972 0
Email 136972 0
Christopher.Partyka@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not at this stage.
Will be revisited upon completion of the study in 2030.


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.