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Trial record 2 of 3 for:    medicortex

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

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ClinicalTrials.gov Identifier: NCT04288167
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
Satasairaala
Information provided by (Responsible Party):
Medicortex Finland Oy

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.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Diagnostic Test: Sample collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Diagnostic
Official Title: Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Biomarker levels [ Time Frame: 12 months ]
    Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay

  2. Biomarker profiles [ Time Frame: 12 months ]
    Characterization of different glycan structures present in the sample by mass spectrometry analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288167


Contacts
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Contact: Mårten Kvist, MD/PhD +358445529334 marten.kvist@medicortex.fi

Locations
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Finland
Satakunta Central Hospital Recruiting
Pori, Finland, 28500
Contact: Sari Malmi, MD    +358262771    sari.malmi@satasairaala.fi   
Sponsors and Collaborators
Medicortex Finland Oy
Satasairaala
Investigators
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Principal Investigator: Sari Malmi, MD Satasairaala
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Responsible Party: Medicortex Finland Oy
ClinicalTrials.gov Identifier: NCT04288167    
Other Study ID Numbers: T257/2019
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data shall not be shared to outside of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating