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Trial registered on ANZCTR


Registration number
ACTRN12620000532909p
Ethics application status
Submitted, not yet approved
Date submitted
8/03/2020
Date registered
30/04/2020
Date last updated
30/04/2020
Date data sharing statement initially provided
30/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Prehospital code crimson activation - the initial experience from the Greater Sydney Area
Scientific title
Prehospital code crimson activation - the initial experience from the Greater Sydney Area
Secondary ID [1] 300788 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 316580 0
Transfusion 316581 0
Haemorrhage control 316582 0
Condition category
Condition code
Emergency medicine 314815 314815 0 0
Resuscitation
Emergency medicine 314897 314897 0 0
Other emergency care
Injuries and Accidents 314898 314898 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In New South Wales, The Institute of Trauma and Injury Management (ITIM) Trauma ‘Prehospital Code Crimson’ protocol was implemented in October 2017. Activation of this protocol is indicated in patients with ‘persistent haemodynamic instability despite standard trauma care, assessed as being secondary to ongoing haemorrhage in blunt or penetrating trauma, which is unresponsive to intravenous fluids and or blood transfusion’. The current protocol involves activation by a prehospital physician which results in both the mobilisation of in-hospital resources including massive transfusion protocol and operating theatre preparation. It also triggers notification to specific interventionalists such as the trauma surgeon and other relevant specialist surgeons as well as the interventional radiologist. This is designed to facilitate a rapid decision, within ten minutes of a patient’s arrival to hospital, as to whether an immediate interventional or operative is needed.

This study is purely a passive observational one and as such does not involve any additional investigation/testing/interviews on top of routine medical care.

Each participants will be observed from the initiation of their prehospital care (point of injury) through to discharge from hospital.
Intervention code [1] 317067 0
Not applicable
Comparator / control treatment
This study is an observational study aiming to describe the patients who had prehospital ‘code crimson’ activation initiated by a GSA-HEMS physician within the first 24 months of policy implementation. There are no control or comparator groups.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323170 0
Mortality
Timepoint [1] 323170 0
within 24 hours of hospital arrival
Secondary outcome [1] 381027 0
Need for in-hospital massive transfusion (as recorded by in-hospital teams in the NSW Trauma Database)
Timepoint [1] 381027 0
within 4 hours of hospital arrival
Secondary outcome [2] 381028 0
Need for interventional haemorrhage control (laparotomy, thoracotomy or angioembolisation) (as recorded by in-hospital teams as procedures performed in the NSW Trauma Database)
Timepoint [2] 381028 0
within 6 hours of hospital arrival

Eligibility
Key inclusion criteria
1. Trauma patients retrieved by Aeromedical operations across the Greater Sydney Area (Bankstown, Wollongong, Orange or Careflight bases) who triggered a prehospital code crimson activation

2. Trauma patients who are identified by the ITIM Trauma Registry as either prehospital Code Crimson activation/Massive Transfusion Protocol (MTP), or have a CT scan within one hour or procedure (see Table 2 in the attached study protocol) within 6 hours or who die in the emergency department
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NSW Trauma Registry patients who do not meet the criteria of a prehospital code crimson response

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
For more detail please refer to the study protocol, provided.

Essentially, the study dataset will be created through joining of the Aeromedical Operations (AO) data with the NSW Trauma Registry. The dataset will be created by performing a ‘left-join’ of all AO prehospital patients with those in the NSW Trauma registry who are identified as meeting the in-hospital requirements for prehospital Code Crimson. To limit the amount of information gathered on patients, only the data required for the linkage will be extracted for the join (see Figure).

Following the join we will be able to identify the following patients:

i ) Those Aeromedical prehospital Code Crimson patients who have a match with NSW Trauma Registry for patients identified as likely meeting code crimson criteria
ii ) Those Aeromedical prehospital Code Crimson patients who do not have a match in the NSW Trauma Registry for patients identified as likely meeting prehospital code crimson criteria (represented by empty fields)
iii) Those NSW Trauma registry patients identified as likely meeting prehospital code crimson criteria but who do not have a match in the Aeromedical operations

We will create a 2x2 table of prehospital code crimson activation to in-hospital outcome to compare the sensitivity and specificity similar to a diagnostic test. Under triage rate will be defined as [prehospital code crimson patients in ITIM dataset not identified as code crimson by AO. Over triage rate will be will defined as [identified as prehospital code crimson by AO but not prehospital code crimson patient in ITIM dataset]. Table 5 (in the protocol) presents how this will be constructed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305195 0
Government body
Name [1] 305195 0
NSW Ambulance (Aeromedical Operations)
Address [1] 305195 0
33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200
Country [1] 305195 0
Australia
Primary sponsor type
Government body
Name
NSW Ambulance (Aeromedical Operations)
Address
33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200
Country
Australia
Secondary sponsor category [1] 305556 0
Government body
Name [1] 305556 0
NSW Institute of Trauma and Injury Management
Address [1] 305556 0
Level 4/67 Albert Ave, Chatswood NSW 2067
Country [1] 305556 0
Australia
Other collaborator category [1] 281228 0
Charities/Societies/Foundations
Name [1] 281228 0
Careflight
Address [1] 281228 0
4-6 Barden St, Northmead NSW 2152
Country [1] 281228 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305550 0
NSW Population and Health Services Research Ethics Committee
Ethics committee address [1] 305550 0
Cancer Institute NSW
Level 9, 8 Central Ave
Australian Technology Park
Eveleigh NSW 2015
Ethics committee country [1] 305550 0
Australia
Date submitted for ethics approval [1] 305550 0
06/03/2020
Approval date [1] 305550 0
Ethics approval number [1] 305550 0

Summary
Brief summary
The purpose of this study is to join these two data sources (prehospital data from NSW State Wide Retrieval Database (SWRD) and Careflight’s retrieval database with in-hospital data from the NSW Trauma database). This will allow us to describe in better detail the patient population in whom a trauma ‘prehospital Code Crimson’ pathway was activated, the rate of requirement for continued in-hospital transfusion of blood products, the need for and timing of early interventions to control haemorrhage following hospital arrival, and the coagulation profile of these patients. It will also aim to review the accuracy of prehospital physicians in determining whether or not their haemodynamically unstable patients will require either ongoing transfusion or interventional haemorrhage control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100758 0
Dr Christopher Partyka
Address 100758 0
Greater Sydney Area HEMS
NSW Ambulance (Aeromedical Operations)
33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200
Country 100758 0
Australia
Phone 100758 0
+61 410585798
Fax 100758 0
+612 8575 7088
Email 100758 0
Christopher.Partyka@health.nsw.gov.au
Contact person for public queries
Name 100759 0
Dr Christopher Partyka
Address 100759 0
Greater Sydney Area HEMS
NSW Ambulance (Aeromedical Operations)
33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200
Country 100759 0
Australia
Phone 100759 0
+61 410585798
Fax 100759 0
+612 8575 7088
Email 100759 0
Christopher.Partyka@health.nsw.gov.au
Contact person for scientific queries
Name 100760 0
Dr Christopher Partyka
Address 100760 0
Greater Sydney Area HEMS
NSW Ambulance (Aeromedical Operations)
33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200
Country 100760 0
Australia
Phone 100760 0
+61 410585798
Fax 100760 0
+612 8575 7088
Email 100760 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
Potential reidentifiable process, given small volume of patients with this degree of injury.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 7284 0
Study protocol
Citation [1] 7284 0
Link [1] 7284 0
Email [1] 7284 0
Other [1] 7284 0
Summary results
No Results