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Trial registered on ANZCTR


Registration number
ACTRN12614000463673
Ethics application status
Approved
Date submitted
23/04/2014
Date registered
2/05/2014
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries: The Australasian Paediatric Head Injury Rules Study (APHIRST)
Scientific title
A prospective observational study of children presenting to the Emergency Department with head injury, comparing three high quality international decision rules regarding CT scan and assess their accuracy in identifying clinically important traumatic brain Injuries
Secondary ID [1] 284460 0
Nil known
Universal Trial Number (UTN)
U1111-1155-8552
Trial acronym
APHIRST (Australasian Paediatric Head Injury Rules Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head Injury 291686 0
Condition category
Condition code
Injuries and Accidents 292067 292067 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
Condition observed: traumatic brain injury on CT scan and clinically important traumatic brain injury.
CT scan is undertaken on a single occasion, only at admission to hospital.
Patients who do not have a CT scan performed in the emergency department receive a telephone call between 14 and 90 days after discharge to administer specific questionnaires and to screen for possible initially missed clinically important traumatic brain injury.

The 3 highest quality clinical decision rules for CT scan in children presenting to the Emergency Department following a head injury are compared in the same cohort of patients.
* CHALICE - Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (Dunning J et al, Arch Dis Child 2006)
* PECARN rule – Paediatric Emergency Care Applied Research Network (Kupperman N at al, Lancet 2009)
* CATCH – Canadian Assessment of Tomography for Childhood Head Injury (Osmond M et al, CAMJ 2010)
Intervention code [1] 289216 0
Not applicable
Comparator / control treatment
The 3 highest quality clinical decision rules for CT scan in children presenting to the Emergency Department following a head injury are compared in the same cohort of patients.
* CHALICE - Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (Dunning J et al, Arch Dis Child 2006)
* PECARN rule – Paediatric Emergency Care Applied Research Network (Kupperman N at al, Lancet 2009)
* CATCH – Canadian Assessment of Tomography for Childhood Head Injury (Osmond M et al, CAMJ 2010)

No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291943 0
Diagnostic accuracy (sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV)) of each of the three clinical decision rules in identifying rule specific outcomes when applied to those patients who meet the individual inclusion and exclusion criteria:

CATCH: need for neurologic intervention or presence of brain injury on CT

CHALICE: clinically significant intracranial injury (CSII), presence of skull fracture, or admission to hospital

PECARN: clinically important traumatic brain injury (ciTBI)
Timepoint [1] 291943 0
Time of CT scan for patients who undergo a CT scan during initial assessment in the emergency department.

Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.
Secondary outcome [1] 307892 0
Rate of ciTBI and CSII in the study population
Timepoint [1] 307892 0
Time of CT scan for patients who undergo a CT scan during initial assessment in the emergency department.

Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.
Secondary outcome [2] 307893 0
Rate of neurosurgical intervention in the study population
Timepoint [2] 307893 0
Time of CT scan for patients who undergo a CT scan during initial assessment in the emergency department.

Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.
Secondary outcome [3] 307894 0
Rate of cranial CT in the study population
Timepoint [3] 307894 0
Time of initial assessment in the emergency department
Secondary outcome [4] 307895 0
Number of missed ciTBI and CSII in the study population
Timepoint [4] 307895 0
Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.
Secondary outcome [5] 307896 0
Number of missed significant intracranial injuries that would have been identified by the application of each clinical decision rule to the study population
Timepoint [5] 307896 0
Time of CT scan for patients who undergo a CT scan during initial assessment in the emergency department.

Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.
Secondary outcome [6] 307897 0
Number of extra cranial CT scans that would be performed by applying each clinical decision rule
Timepoint [6] 307897 0
Time of CT scan for patients who undergo a CT scan during initial assessment in the emergency department.

Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.
Secondary outcome [7] 307898 0
Sensitivity, specificity, NPV and PPV of PECARN in identifying traumatic brain injury on CT
Timepoint [7] 307898 0
Time of initial assessment in the emergency department
Secondary outcome [8] 307899 0
Diagnostic accuracy of each of the clinical decision rule when applied to those patients attending with head injury who do not meet the specific individual inclusion and exclusion criteria
Timepoint [8] 307899 0
Time of initial assessment in the emergency department
Secondary outcome [9] 307900 0
Rules diagnostic accuracy in patients with bleeding diathesis, ventriculoperitoneal shunts and non-accidental injuries
Timepoint [9] 307900 0
Time of CT scan for patients who undergo a CT scan during initial assessment in the emergency department.

Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.
Secondary outcome [10] 307902 0
Rate of prolonged symptoms following a non-severe head injury.
This outcome will be assessed by means of an author developed questionnaire (based on the follow up questions used by the PECARN and CATCH investigators)
Timepoint [10] 307902 0
Within 3 months for patients who do not undergo neuroimaging at the time of initial assessment. These patients receive a structured telephone follow up within 3 months from initial assessment.

Eligibility
Key inclusion criteria
Patients between birth and less than 18 years of age with head injuries of all severities. The definition of head injury does not include patients who have sustained a trivial facial injury defined as a ground level fall or walking or running into an object with no signs or symptoms of injury other than facial abrasions or lacerations below the eyebrows.
Minimum age
0 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Refusal to participate to the study
- Direct referral from the emergency department triage to a general practitioner or other external provider (i.e. not seen in the emergency department)
- Departure from the emergency department before being seen
- Neuroimaging prior to presentation for the same injury

Individual exclusion criteria (relevant to each Clinical Decision Rule) will be applied when comparing data with each Clinical Decision Rule.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 6013 0
New Zealand
State/province [1] 6013 0

Funding & Sponsors
Funding source category [1] 289105 0
Government body
Name [1] 289105 0
National Health and Medical Research Council
Address [1] 289105 0
16 Marcus Clarke Street
Canberra
ACT 2601
Country [1] 289105 0
Australia
Primary sponsor type
Individual
Name
Prof Franz Babl
Address
Murdoch Children's Research Institute
50, Flemington Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 287771 0
Charities/Societies/Foundations
Name [1] 287771 0
Perpetual Trustees
Address [1] 287771 0
35/525 Collins St,
Melbourne
VIC 3000
Country [1] 287771 0
Australia
Secondary sponsor category [2] 287788 0
Charities/Societies/Foundations
Name [2] 287788 0
Queensland Emergency Medicine Research Foundation
Address [2] 287788 0
2/15
Lang Parade
Milton
QLD 4064
Country [2] 287788 0
Australia
Secondary sponsor category [3] 287789 0
Charities/Societies/Foundations
Name [3] 287789 0
Auckland Medical Research Foundation
Address [3] 287789 0
89 Grafton Road
PO Box 110139
Auckland Hospital
Auckland 1148
Country [3] 287789 0
New Zealand
Other collaborator category [1] 277922 0
Other Collaborative groups
Name [1] 277922 0
PREDICT (Paediatric Research in Emergency Departments International Collaborative)
Address [1] 277922 0
Murdoch Children's Research Institute
50, Flemington Road
Parkville
VIC 3052
Country [1] 277922 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290891 0
The Royal Children’s Hospital, Melbourne- Human Research Ethics Committee
Ethics committee address [1] 290891 0
50, Flemington Road
Parkville
3052
VIC
Ethics committee country [1] 290891 0
Australia
Date submitted for ethics approval [1] 290891 0
Approval date [1] 290891 0
02/02/2011
Ethics approval number [1] 290891 0
31008A

Summary
Brief summary
Children with clinically significant intracranial injuries require rapid identification in the acute care setting in order to prevent further damage to the brain. Head CT scans can quickly identify the presence or absence of intracranial injuries, and help guide subsequent management (including neurosurgical intervention) where intracranial injuries are identified. However, head CT scans also have negative effects, particularly in children, who are more vulnerable to radiation-associated cell damage and may require sedation to allow imaging with consequent sedation-associated risks. Radiation from cranial CT scans can cause lethal malignancies later in life, with a reported cancer related mortality between 1:1000 and 1:10000 paediatric cranial CT scans, with higher risk in younger age groups. They also have resource implications for Emergency Departments and the health system as a whole. Despite this, the number of cranial CT scans performed for head injuries in children is increasing, in part due to concern amongst physicians regarding the consequences of being unable to reliably identify intracranial injury based solely on a child’s clinical condition.
Clinical decision rules are a combination of clinical variables. These may include elements of the patient's history, physical examination findings, or simple tests that guide clinicians in their decision making process for optimal patient care. There are three high-quality, international clinical decision rules that have been developed to decide which children need a CT scan following a head injury and which can be safely managed without. They are very accurate in identifying children with intracranial injuries, however they are quite different in terms of applicable populations and definitions of a significant intracranial injury. In addition these three rules have not been compared in the same population to assess which is the best rule to be used in clinical practice.

The primary aim of the current study is to determine the accuracy of the three major international paediatric head injury clinical decision rules when applied to a single population of consecutive children presenting to the Emergency Department with head injury in Australia and New Zealand.

The hypothesis is that the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting, will allow the determination of the optimal rule for use in the Australasian Emergency Department setting.
Trial website
Trial related presentations / publications
Babl FE, Borland M, Phillips N, Kochar A, Dalton S, McCaskill M, Cheek J, Gilhotra Y, Furyk J, Neutze J, Lyttle M, Bressnan S, Donath S, Molesworth C, Jachno K, Ward B, Williams A, Baylis A, Crowe L, Oakley E, Dalziel S. Accuracy of PECARN, CATCH, and CHALICE head injury decision rules in children: a prospective cohort study. Lancet. 2017: 389: 2393-402

Pfeiffer H, Smith A, Kemp AM, Cowley LE, Cheek JA, Dalziel SR, Borland ML, O’Brien S, Bonisch M, Neutze J, Oakley E, Crowe L, Hearps S, Lyttle MD, Bressan S, Babl FE; Paediatric Research in Emergency Department International Collaborative (PREDICT). External Validation of the PediBIRN Clinical Prediction Rule for Pediatric Abusive Head Trauma. Pediatrics. 2018 Apr 26. pii: e20173674. doi: 10.1542/peds.2017-3674. [Epub ahead of print]

Borland ML, Dalziel SR, Phillips N, Dalton S, Lyttle MD, Bressan S, Oakley E, Hearps SJC, Kochar A, Furyk J, Cheek JA, Neutze J, Babl FE. Vomiting with Head Tauma and Risk of Traumatic Brain Injury. Pediatrics. 2018 Apr;141(4). pii: e20173123. doi: 10.1542/peds.2017-3123.

Crowe LM, Hearps S, Anderson V, Borland M, Phillips N, Kochar A, Dalton S, Cheek JA, Gilhotra Y, Furyk J, Neutze J, Lyttle MD, Bressan S, Donath S, Molesworth C, Oakley E, Dalziel SR, Babl FE. Investigating the variability in mild traumatic brain injury definitions: a prospective cohort study. Arch Phys Med Rehabil. 2018 Jan 30. pii: S0003-9993(18)30042-X. doi: 10.1016/j.apmr.2017.12.026. [Epub ahead of print]

Daverio M, Babl FE, Barker R, Gregori D, Da Dalt L, Bressan S; Paediatric Research in Emergency Department International Collaborative (PREDICT) group. Helmet use in preventing acute concussive symptoms in recreational vehicle related head trauma. Brain Inj. 2018;32(3):335-341. doi: 10.1080/02699052.2018.1426107. Epub 2018 Jan 22.

Babl FE, Lyttle MD, Bressan S, Borland ML, Phillips N, Kochar A, Dalton S, Cheek JA, Gilhotra Y, Furyk J, Neutze J, Donath S, Hearps S, Arpone M, Crowe L, Dalziel SR, Barker R, Oakley E. Penetrating head injuries in children presenting to the emergency department in Australia and New Zealand. A PREDICT prospective study. J Paediatr Child Health. 2018 Mar 26. doi: 10.1111/jpc.13903. [Epub ahead of print]

Babl FE, Oakley E, Dalziel S, Borland ML, Phillips N, Kochar A, Dalton S, Cheek JA, Gilhotra Y, Furyk J, Neutze J, Donath S, Hearps S, Molesworth C, Crowe L, Bressan S, Lyttle MD.
Accuracy of Physician Practice Compared With Three Head-Injury Decision Rules in Children A Prospective Cohort Study. Ann Emergency Medicine. 2018 Feb 13. pii: S0196-0644(18)30028-3. doi: 10.1016/j.annemergmed.2018.01.015. [Epub ahead of print]


Public notes

Contacts
Principal investigator
Name 47818 0
A/Prof Franz Babl
Address 47818 0
Murdoch Childrens Research Institute and The Royal Children’s Hospital, Melbourne
Flemington Road
Parkville
VIC 3052
Country 47818 0
Australia
Phone 47818 0
+61399366635
Fax 47818 0
Email 47818 0
Franz.Babl@rch.org.au
Contact person for public queries
Name 47819 0
A/Prof Franz Babl
Address 47819 0
Murdoch Childrens Research Institute and The Royal Children’s Hospital, Melbourne
Flemington Road
Parkville
VIC 3052
Country 47819 0
Australia
Phone 47819 0
+61399366635
Fax 47819 0
Email 47819 0
Franz.Babl@rch.org.au
Contact person for scientific queries
Name 47820 0
A/Prof Franz Babl
Address 47820 0
Murdoch Childrens Research Institute and The Royal Children’s Hospital, Melbourne
Flemington Road
Parkville
VIC 3052
Country 47820 0
Australia
Phone 47820 0
+61399366635
Fax 47820 0
Email 47820 0
Franz.Babl@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary