ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000532909

Ethics application status

Approved

Date submitted

8/03/2020

Date registered

30/04/2020

Date last updated

23/09/2021

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Trauma

Transfusion

Haemorrhage control

Condition category

Condition code

Emergency medicine

Resuscitation

Emergency medicine

Other emergency care

Injuries and Accidents

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]

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]

Mortality

Timepoint [1]

within 24 hours of hospital arrival

Secondary outcome [1]

Need for in-hospital massive transfusion (as recorded by in-hospital teams in the NSW Trauma Database)

Timepoint [1]

within 4 hours of hospital arrival

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/05/2020

Actual

2/02/2021

Date of last participant enrolment

Anticipated

1/06/2020

Actual

23/02/2021

Date of last data collection

Anticipated

1/07/2020

Actual

8/03/2021

Sample size

Target

Accrual to date

Final

128

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Ambulance (Aeromedical Operations)

Address [1]

33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200

Country [1]

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]

Government body

Name [1]

NSW Institute of Trauma and Injury Management

Address [1]

Level 4/67 Albert Ave, Chatswood NSW 2067

Country [1]

Australia

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Careflight

Address [1]

4-6 Barden St, Northmead NSW 2152

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NSW Population and Health Services Research Ethics Committee

Ethics committee address [1]

Cancer Institute NSW
Level 9, 8 Central Ave 
Australian Technology Park 
Eveleigh NSW 2015

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/03/2020

Approval date [1]

12/06/2020

Ethics approval number [1]

2020/ETH00243

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

Dr Christopher Partyka

Address

Greater Sydney Area HEMS
NSW Ambulance (Aeromedical Operations)
33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200

Country

Australia

Phone

+61 410585798

Fax

+612 8575 7088

[email protected]

Contact person for public queries

Name

Christopher Partyka

Address

Greater Sydney Area HEMS
NSW Ambulance (Aeromedical Operations)
33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200

Country

Australia

Phone

+61 410585798

Fax

+612 8575 7088

[email protected]

Contact person for scientific queries

Name

Christopher Partyka

Address

Greater Sydney Area HEMS
NSW Ambulance (Aeromedical Operations)
33 Nancy Ellis Leebold Drive, Bankstown Airport NSW 2200

Country

Australia

Phone

+61 410585798

Fax

+612 8575 7088

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7284	Study protocol					379425-(Uploaded-08-03-2020-21-50-08)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prehospital activation of a coordinated multidisciplinary hospital response in preparation for patients with severe hemorrhage: A statewide data linkage study of the New South Wales "Code Crimson" pathway.	2022	https://dx.doi.org/10.1097/TA.0000000000003585

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically