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

April 30, 2021 updated by: Medicortex Finland Oy
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Pori, Finland, 28500
        • Satakunta Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Sample collection
Samples of urine and saliva will be collected from participants using customary sample collection means.
Active Comparator: 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.
Diagnostic test: Sample collection
Samples of urine and saliva will be collected from participants using customary sample collection means.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker levels
Time Frame: 12 months
Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay
12 months
Biomarker profiles
Time Frame: 12 months
Characterization of different glycan structures present in the sample by mass spectrometry analysis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicortex Finland Oy

Collaborators

Satasairaala

Investigators

  • Principal Investigator: Sari Malmi, MD, Satasairaala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2020

Primary Completion (Actual)

April 14, 2021

Study Completion (Actual)

April 14, 2021

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T257/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data shall not be shared to outside of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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