ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000887976

Ethics application status

Approved

Date submitted

26/06/2020

Date registered

9/09/2020

Date last updated

9/09/2020

Date data sharing statement initially provided

9/09/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Does the use of the Canadian CT Head rule (CCHR) definition of minor head injury in a regional NSW emergency department safely lead to lower utilisation of computer tomography (CT) imaging in patients over 65 when compared to the NSW Closed Head Injury guidelines definition?

Scientific title

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1253-0105

Trial acronym

Linked study record

Health condition

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

Mild head injury

mild traumatic brain injury

minor head trauma

Condition category

Condition code

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

The study will combine both a retrospective and prospective arm assessing patients over 65 who present to the Port Macquarie Base Hospital emergency department (PMBH ED) after a blunt head trauma.

The retrospective arm will involve a chart review of patients who presented due to head trauma from January-Decemeber 2019 and received a computerised tomography (CT) scan. Each patient electronic medical record (EMR) will be retrospectively assessed for the following features:
1. The presence of Canadian CT Head Rule (CCHR) inclusion criteria: Glasgow Coma Scale (GCS) of 13-15 with one of the following: witnessed loss of consciousness, definite amnesia or witnessed disorientation post blunt head trauma
2. The presence of CCHR exclusion criteria: anticoagulation, dementia, intoxication, bleeding disorder, penetrating skull injury, depressed skull fracture, acute focal neurological deficit that can’t be ascribed to an extracerebral cause, no history of trauma as the primary event eg. syncope, post-traumatic seizure, unstable vitals due to trauma or reassessment of the same head injury
3. CT results and patient outcome
4. Length time from ordering to reporting of imaging within 24 hours
5. Miscellaneous: antiplatelet medication

It will then be determined whether the patient should have undergone a CT brain according to the CCHR definition of minor head injury (MHI).

Within the prospective arm of the study, all patients over 65 that present to PMBH ED from 13th July- 31st August 2020 post blunt head injury will be prospectively enrolled. Clinicians ordering a CT Brain in this population will be asked to answer questions via a pop up link in EMR that will auto-populate. This data will be cross-checked with the patients electronic medical record and additionally assessed for the above features. After the data is collected it will then be analysed to see if applying the more restrictive CCHR definition of minor head injury can safely decrease the utilisation of CT Brains in this population without missing a clinically significant brain injury.

Clinically significant brain injury is defined according to the CCHR as any acute brain finding on CT which would normally require admission to hospital and neurological follow-up unless the patient is neurologically intact and has one of the following lesions: solitary contusion less than 5 mm in diameter; localised subarachnoid blood less than 1mm thick; smear subdural haematoma less than 4 mm thick; isolated pneumocephaly, or closed depressed skull fracture not through the inner table.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

The comparator is the NSW Closed Head Injury guidelines definition of minor head injury (MHI) which is currently applied as part of standard care to all patients who present to PMBH ED following blunt head trauma. These guidelines define MHI as a patient with an initial Glasgow coma scale (GCS) of 14-15 following acute blunt head trauma, with or without loss of consciousness or post-traumatic amnesia. Both the retrospective and prospective arms are used for the comparator group.

Control group

Active

Outcomes

Primary outcome [1]

Sensitivity of the Canadian CT Head Rule definition of minor head injury to detect clinically significant head injury. The true positive rate for MHI will be assessed from the Canadian Ct Head Rule when compared to the reference standard (NSW Closed Head Injury Guidelines).

Timepoint [1]

Within 2 months post data-collection completion

Primary outcome [2]

Specificity of the CCHR definition of minor head injury to detect clinically significant head injury. The true negative rate for MHI will be assessed for the Canadian CT Head Rule when compared to the reference standard (NSW Closed Head injury Guidelines).

Timepoint [2]

Within 2 months post-data collection completion

Secondary outcome [1]

Any change in the number of CT brain scans conducted through application of the CCHR definition of minor head injury (MHI). The number of CT brain scans will be determined for each cohort using radiology request records for CT brains.

Timepoint [1]

Within 2 months post-data collection completion

Secondary outcome [2]

Cost to the health care system calculated using the potential reduction in CT brain scans

Timepoint [2]

Within 2 months post-data collection completion

Secondary outcome [3]

Patient time spent in the emergency department, measured in time from CT brain ordering to reporting using patient electronic medical records.

Timepoint [3]

Within 2 months post-data collection completion

Eligibility

Key inclusion criteria

Patients over 65 who received at CT brain due to head injury with a Glasgow coma scale of 13-15.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Age <65 years
Glasgow coma scale <13
Alzheimer’s disease
Intoxication at time of CT
Anticoagulation medication
Bleeding disorder
Post-traumatic seizure
Penetrating skull injury
Depressed skull fracture
Acute focal neurological deficit that cannot be ascribed to an extracerebral cause
No history of trauma as the primary event eg. syncope, seizure
Unstable vital signs due to trauma
Reassessment of the same head injury

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Both

Statistical methods / analysis

We aim to analyse all patients who received a CT brain at PMBH ED due to blunt head trauma in 2019. There were a total of 2971 CT brains conducted during 2019. Patients under the age of 65 (n=893) were removed from this dataset, resulting in a total of 2078 CT brains conducted in over 65 year olds in 2019. We conducted a pilot study on 100 random patients and determined that 52% of patients underwent a CT brain due to minor head trauma. When this data is extrapolated to the entire data set, we estimate that 1080 patients will be included for analysis in our study.

We plan to conduct a sensitivity and specificity analysis in addition to a cost-benefit analysis using IBM SPSS. We will also calculate the percentage reduction in the number of CT brains due to the application of the CCHR definition of MHI.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

13/07/2020

Date of last participant enrolment

Anticipated

31/12/2020

Actual

Date of last data collection

Anticipated

14/01/2021

Actual

Sample size

Target

1080

Accrual to date

259

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Port Macquarie Base Hospital - Port Macquarie

Recruitment postcode(s) [1]

2444 - Port Macquarie

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of New South Wales

Address [1]

Sydney NSW 2052

Country [1]

Australia

Primary sponsor type

University

Name

University of New South Wales

Address

Sydney NSW 2052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The North Coast NSW Human Research Ethics Committee

Ethics committee address [1]

NCNSW Human Research Ethics Committee
PO Box 821 Murwillumbah NSW 2484

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/11/2019

Approval date [1]

08/03/2020

Ethics approval number [1]

(HREA270) 2019/ETH13659

Summary

Brief summary

Mild head injury (MHI) in the elderly population is a very common presenting complaint to the emergency department. After assessment, the main decision health providers need to make is whether or not the patient requires a CT Brain to assess for significant intra-cranial injury such as intracranial haemorrhage. Current NSW Health Head Injury guidelines define a minor head injury as “a patient with an initial Glasgow Coma Score (GCS) of 14-15 on arrival at hospital following acute blunt head trauma with or without a definite history of loss of consciousness or post traumatic amnesia”. As a result of this broad definition, almost all patients in NSW who present to the emergency department after blunt head trauma undergo a CT scan. In comparison, the “Canadian CT Head Rule (CCHR)”, which is the most commonly used and validated clinical decision rule around head injury, defines MHI as a patient with a GCS of 13-15 and who has one of the following; sustains a period of loss of consciousness, post- traumatic amnesia or disorientation post head impact. Using this inclusion criteria, the CCHR definition and rule was shown to be 100% sensitive and 69% specific for the need for detecting need for neuro-surgical interventions post head injury. It was also 98% sensitive and 50% specific for detecting clinically significant brain injury. Our study will aim to assess whether the use of this more restrictive imaging strategy can safely reduce the number of CT Brains ordered post MHI in a regional NSW emergency department.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Thomson

Address

Port Macquarie Base Hospital Emergency Department. Wrights Road Port Macquarie NSW 2444

Country

Australia

Phone

+61435153774

Fax

[email protected]

Contact person for public queries

Name

Dr David Thomson

Address

Port Macquarie Base Hospital Emergency Department. Wrights Road Port Macquarie NSW 2444

Country

Australia

Phone

+61435153774

Fax

[email protected]

Contact person for scientific queries

Name

Dr David Thomson

Address

Port Macquarie Base Hospital Emergency Department. Wrights Road Port Macquarie NSW 2444

Country

Australia

Phone

+61435153774

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

We do not have ethics approval for this.

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
8324	Study protocol	[email protected]
8325	Ethical approval	[email protected]
8326	Other		Data extraction sheet	380065-(Uploaded-24-06-2020-13-06-31)-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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically