Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents

Medicortex

Status: Completed

Conditions: Brain Injuries, Traumatic

Treatments: Diagnostic Test: Sample collection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04288167

T257/2019

Details and patient eligibility

About

The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.

Full description

The collected samples will be alienated to the Sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.

Enrollment: 58 patients

Sex: All

Ages: 1 minute to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The subject is suspected of having an isolated mild TBI (Glasgow Coma Score 13 - 15)
• No more that 6 hours elapsed from the incident of injury at the first sampling
• The patient is conscious
• Informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures

Exclusion criteria

• More than 6 hours elapsed from the injury, or unknown time of trauma
• Multi-trauma patient
• History of head injury, seizures or stroke within three preceding months
• Chronic neurodegenerative, metabolic or autoimmune disease
• Known existing neurological condition

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Patients with suspected brain injury

Experimental group

Description:

This arm will consist of up to 30 pediatric patients who entered the Emergency Room and who are suspected of having mild traumatic brain injury. Two sample sets will be collected within the first 10 hours from the injury.

Treatment:

Diagnostic Test: Sample collection

Healthy controls

Active Comparator group

Description:

This arm will consist of up to 30 healthy control subjects, the samples of whom will be compared to the samples of brain injury patients (Arm 1). One sample set will be collected from healthy children without any known brain injury.

Treatment:

Diagnostic Test: Sample collection