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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-14

Study Completion Date

2021-04-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Injuries, Traumatic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

The laboratories will analyze the samples blinded, without knowing whether the sample was from an injured patient or a healthy control.

Study Groups

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Patients with suspected brain injury

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.

Group Type EXPERIMENTAL

Sample collection

Intervention Type DIAGNOSTIC_TEST

Samples of urine and saliva will be collected from participants using customary sample collection means.

Healthy controls

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.

Group Type ACTIVE_COMPARATOR

Sample collection

Intervention Type DIAGNOSTIC_TEST

Samples of urine and saliva will be collected from participants using customary sample collection means.

Interventions

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Sample collection

Samples of urine and saliva will be collected from participants using customary sample collection means.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes