Identification of biomarkers that correlate with clinical features and outcomes following concussion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615000543583

Enrollment

Registered

2015-05-28

Start date

2015-09-26

Completion date

2017-12-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a study of patients presenting to the Emergency Department (ED) with concussion. Clinical data, imaging, neuropsychological testing and blood samples of patients with concussion will be correlated with outcomes. This may lead to the development of improved tools for diagnosis and prognosis, which could be used in future trials of treatment for concussion.

Interventions

An observation of concussion for 28 days. Neuropsychological tests, biomarker levels and will be conducted on the day of presentation to the emergency department; MRI imaging will be conducted within the first week after injury where feasible. Neuropsychological tests and biomarker assays will be repeated at day 28; MRI will be repeated at day 28 if the first MRI was abnormal.

Eligibility

Sex/Gender

All

Age

14 Years to 50 Years

Healthy volunteers

Inclusion criteria

a. Patients between 14 and less than 50 years of age b. Presenting to ED within 48 hours of head injury with symptoms that may be attributable to that injury c. Cranial CT scan shows no intracranial injury, or CT was not performed Age and sex matched control subjects will be recruited from healthy volunteers known to the researchers.

Exclusion criteria

a. Glasgow Coma Scale (GCS) 13 or less at time of initial assessment. b. Ward of state, prisoner, under mental health treatment order. c. Deemed unlikely to comply with 28 day follow up e.g. homeless. d. Head injury deemed to be entirely due to primary seizure. e. Clinically unstable from other injury or other significant non-TBI injury. f. Non English speaking. g. Known pre-existing cognitive impairment, such as an intellectual disability.

Outcome results