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

NCT04288167 | Completed DMC

• 1 other identifier: T257/2019
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (2)

• Biomarker levels

  Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay

  12 months

• Biomarker profiles

  Characterization of different glycan structures present in the sample by mass spectrometry analysis

  12 months

Study Arms (2)

Patients with suspected brain injury

EXPERIMENTAL

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.

Diagnostic Test: Sample collection

Healthy controls

ACTIVE COMPARATOR

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.

Diagnostic Test: Sample collection

Interventions

Sample collection DIAGNOSTIC_TEST

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

Healthy controls; Patients with suspected brain injury

Eligibility Criteria

• Age: 1 Minute - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicortex Finland Oy: lead
• Satasairaala: collaborator

Study Sites (1)

Satakunta Central Hospital

Pori, 28500, Finland

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Sari Malmi, MD

  Satasairaala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The laboratories will analyze the samples blinded, without knowing whether the sample was from an injured patient or a healthy control.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 28, 2020
• Study Start: May 14, 2020
• Primary Completion: April 14, 2021
• Study Completion: April 14, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)