Back to resultsBiochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Primary Purpose
Brain Injuries, Traumatic
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Sample collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Injuries, Traumatic
Eligibility Criteria
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
Sites / Locations
- Satakunta Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with suspected brain injury
Healthy controls
Arm 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.
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.
Outcomes
Primary Outcome Measures
Biomarker levels
Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay
Biomarker profiles
Characterization of different glycan structures present in the sample by mass spectrometry analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT04288167
First Posted
February 13, 2020
Last Updated
April 30, 2021
Sponsor
Medicortex Finland Oy
Collaborators
Satasairaala
1. Study Identification
Unique Protocol Identification Number
NCT04288167
Brief Title
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Official Title
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
April 14, 2021 (Actual)
Study Completion Date
April 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicortex Finland Oy
Collaborators
Satasairaala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The laboratories will analyze the samples blinded, without knowing whether the sample was from an injured patient or a healthy control.
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with suspected brain injury
Arm Type
Experimental
Arm 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.
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sample collection
Intervention Description
Samples of urine and saliva will be collected from participants using customary sample collection means.
Primary Outcome Measure Information:
Title
Biomarker levels
Description
Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay
Time Frame
12 months
Title
Biomarker profiles
Description
Characterization of different glycan structures present in the sample by mass spectrometry analysis
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sari Malmi, MD
Organizational Affiliation
Satasairaala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satakunta Central Hospital
City
Pori
ZIP/Postal Code
28500
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data shall not be shared to outside of the study.
Learn more about this trial
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
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