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Trial registered on ANZCTR


Registration number
ACTRN12620000022965
Ethics application status
Approved
Date submitted
9/12/2019
Date registered
15/01/2020
Date last updated
15/01/2020
Date data sharing statement initially provided
15/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Discovery of serum biomarkers for the diagnosis of sport-related concussion in children.
Scientific title
Discovery of serum biomarkers for the diagnosis of sport-related concussion in children.
Secondary ID [1] 299619 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports related concussion 314922 0
Minor traumatic brain injury 314923 0
Condition category
Condition code
Neurological 313278 313278 0 0
Other neurological disorders
Injuries and Accidents 313279 313279 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
2 groups of participants will be observed. Healthy controls and patient's with a diagnosed sports related concussion/minor traumatic brain injury. Diagnosis will be confirmed by medical specialists through a medical history and examination. Further evaluation will use the Sports Concussion Assessment Tool 5 and other cognitive assessment tools.

Concussion may be caused either by a direct blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head.

Concussion typically results in the rapid onset of short-lived impairment of neurological function that resolves spontaneously. However, in some cases, signs and symptoms evolve over a number of minutes to hours.

Concussion may result in neuropathological changes, but the acute clinical signs and symptoms largely reflect a functional disturbance rather than a structural injury and, as such, it is currently thought that no abnormality is seen on standard structural neuro-imaging studies.

Concussion results in a range of clinical signs and symptoms that may or may not involve loss of consciousness. Resolution of the clinical and cognitive features typically follows a sequential course. However, in some cases symptoms may be prolonged.

We will observe patients diagnosed with a concussion for a total of 28 days, over which time participants will undergo clinical evaluation, cognitive testing and exercise testing, in addition to measurement of serum biomarkers.

Healthy participants will have a single measurement of the biomarkers to determine normative values for non-concussed, age matched participants.
Intervention code [1] 315877 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy controls will be an age and sex matched group consisting of individuals with no history of a concussion. They will undergo serum biomarker testing on one occasion.
Control group
Active

Outcomes
Primary outcome [1] 322020 0
Serum tryptase levels over time following a concussion.
Timepoint [1] 322020 0
1-3 days (primary timepoint) following a concussion and then repeated at 7, 14 and 28 days to assess how long levels remain elevated.
Secondary outcome [1] 377045 0
Cognitive function as assessed by ImPACT.
Timepoint [1] 377045 0
1-3 days following a concussion and then repeated at 7, 14 and 28 days.
Secondary outcome [2] 377952 0
Concsussion symptoms as assessed using the Sports Concussion Assessment Tool.
Timepoint [2] 377952 0
1-3 days following a concussion and then repeated at 7, 14 and 28 days.
Secondary outcome [3] 377953 0
Exercise Tolerance as assessed using a treadmill Bruce protocol
Timepoint [3] 377953 0
1-3 days following a concussion and then repeated at 7, 14 and 28 days.

Eligibility
Key inclusion criteria
Males and females between the ages of 10-18 years participating in high-contact (impact) sports (patients) and age and sex matched young people not involved in high-contact (impact) sports (controls).
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants with acute exacerbation of allergic inflammation including but not restricted to asthma, eczema, food allergy or anaphylaxis, individuals with recent head injury (<6 months), existing neurological or non-neurological chronic diseases, recent major surgery or those who suffered multiple injuries in the current incident will be excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Using tryptase as the primary outcome and based on already established/validated normal values for healthy subjects and where a 2-fold or more increase from the 95th percentile value is considered pathological, we set a minimum 2-fold increase in the average amounts of tryptase (ng/ml ± 2SD) of patient sera as compared to the average levels in control sera. Based on disease severity according to the SCAT5 and expected number of dropouts on follow up, a sample size of 100 subjects with SRC and 100 healthy controls will be sufficient to detect differences at 95% confidence between patients with concussion and healthy controls, as well as among subjects with increasing severity of disease, if the accepted Type I error is set at 0.05. Our power calculation figure of 85 should therefore be met with a margin of 15 patients lost to drop out.

Logistic regression will be used at the initial time-point to assess the ability of a given biomarker(s) to distinguish between patients with concussive injury and healthy controls. Levels of each biomarker in healthy controls will then be compared to levels in patient sera at each time point using one-way ANOVA with appropriate post-test for multiple comparisons. Linear regression analysis and Spearman correlations will be used to examine the relationship between serum levels of each biomarker and disease severity in patients as determined by SCAT5 and A-WPTAS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15269 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 28578 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 304096 0
Commercial sector/Industry
Name [1] 304096 0
Bio Island
Country [1] 304096 0
Australia
Primary sponsor type
University
Name
UNSW
Address
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 304568 0
Hospital
Name [1] 304568 0
The Children's Hospital at Westmead
Address [1] 304568 0
Cnr Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
Country [1] 304568 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304585 0
Sydney Children's Hospital Netowrk Human Research Ethics Commitee (SCHN HREC)
Ethics committee address [1] 304585 0
Ethics committee country [1] 304585 0
Australia
Date submitted for ethics approval [1] 304585 0
03/06/2019
Approval date [1] 304585 0
02/10/2019
Ethics approval number [1] 304585 0
2019/ETH00151

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

Contacts
Principal investigator
Name 97482 0
Dr David Jefferies
Address 97482 0
Children's Institute of Sports Medicine,
The Children's Hospital at Westmead,
Cnr Hawkesbury Rd &, Hainsworth St,
Westmead NSW 2145.
Country 97482 0
Australia
Phone 97482 0
+61 2 9845 0761
Fax 97482 0
Email 97482 0
david.jefferies@health.nsw.gov.au
Contact person for public queries
Name 97483 0
Gary Browne
Address 97483 0
Children's Institute of Sports Medicine,
The Children's Hospital at Westmead,
Cnr Hawkesbury Rd &, Hainsworth St,
Westmead NSW 2145.
Country 97483 0
Australia
Phone 97483 0
+61 2 9845 0761
Fax 97483 0
Email 97483 0
gary.browne@health.nsw.gov.au
Contact person for scientific queries
Name 97484 0
Gary Browne
Address 97484 0
Children's Institute of Sports Medicine,
The Children's Hospital at Westmead,
Cnr Hawkesbury Rd &, Hainsworth St,
Westmead NSW 2145.
Country 97484 0
Australia
Phone 97484 0
+61 2 9845 0761
Fax 97484 0
Email 97484 0
gary.browne@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
Data will be stored anonymously and will only be used for the purposes of this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5834Ethical approval    378606-(Uploaded-02-12-2019-14-52-52)-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.