<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03306563</url>
  </required_header>
  <id_info>
    <org_study_id>T213/2017</org_study_id>
    <nct_id>NCT03306563</nct_id>
  </id_info>
  <brief_title>Rapid Biochemical Diagnostics of Traumatic Brain Injury</brief_title>
  <official_title>Rapid Biochemical Diagnostics of Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medicortex Finland Oy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medicortex Finland Oy</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to confirm the clinical relevance of the novel biomarker for&#xD;
      traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected&#xD;
      from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c)&#xD;
      healthy controls. The sponsor will do biochemical investigations for the samples to evaluate&#xD;
      the presence, level and structure of the targeted biomarker.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will analyze and compare the levels of certain biomolecules and cellular&#xD;
      degradation products which are released upon a brain injury and which become detectable in&#xD;
      the body fluids. Patients with a traumatic brain injury are supposed to express these&#xD;
      biomarkers in their body fluids while orthopedic trauma patients and healthy controls are&#xD;
      supposed to be undetectable with respect to these biomolecules. The study is a case-control&#xD;
      study where the study subjects with a property (injured) are compared to subjects without the&#xD;
      property (healthy). The brain injury patient group will consist of subjects who entered the&#xD;
      Emergency Department of the hospital with a suspected TBI. The orthopedic patient group will&#xD;
      consists of patients who were admitted with a bone fracture in the limbs, but without a&#xD;
      suspected TBI. The control group will consist of healthy subjects who will be recruited to&#xD;
      the study by the activities of the study personnel.&#xD;
&#xD;
      The entire study is split into two successive parts. In the first Part I, 18 - 24 subjects&#xD;
      will be recruited in each group. In the second part, the number of the patients with&#xD;
      suspected TBI will be added to up to 100 in order to receive an adequate number of samples&#xD;
      and to gain sufficient statistical significance between the brain injury severities and in&#xD;
      successive sampling time points.&#xD;
&#xD;
      The collected samples and relevant clinical data of each subject will be supplied to the&#xD;
      sponsor who will perform to the samples 1) Biochemical analysis for the presence and level of&#xD;
      the biomarker, and 2) Biomarker profiling and structure analysis by LC/MS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 28, 2017</start_date>
  <completion_date type="Actual">June 7, 2021</completion_date>
  <primary_completion_date type="Actual">January 23, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Total of 160 patients Phase 2a, 60 patients divided in three groups with TBI, orthopedic injury, and healthy volunteers (controls).&#xD;
Phase 2b: 100 patients with concussion and mild traumatic brain injury.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Analytical evaluation and testing laboratories will get the samples blinded (coded).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Biomarker level</measure>
    <time_frame>One year (1 year)</time_frame>
    <description>Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Concussion, Mild</condition>
  <condition>Bone Fracture</condition>
  <arm_group>
    <arm_group_label>Patients with suspected TBI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group will consist of patients who have arrived in the hospital with head injury and suspected isolated TBI. Sample collection (up to five times) and assessment of neurological status.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orthopedic patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group will consist of patients with orthopedic injury, but without a head injury and suspected TBI. Sample collection (once).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The group will consist of healthy controls who do not have a recent trauma history. Sample collection (once).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sample collection</intervention_name>
    <description>Samples of blood, urine and saliva will be collected at up to five successive time points.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Orthopedic patients</arm_group_label>
    <arm_group_label>Patients with suspected TBI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent form (Finnish or Swedish)&#xD;
&#xD;
          -  Age 18 - 75 years (Male or Female)&#xD;
&#xD;
          -  For patients with a suspected TBI: Presenting to the ED within 4 hours after the&#xD;
             injury, and no orthopedic trauma (fractures of long bones) present.&#xD;
&#xD;
          -  For patients with a suspected TBI: Deemed to have a computed tomography (CT) scan as a&#xD;
             part of their intended medical diagnosis and treatment.&#xD;
&#xD;
          -  For patients with orthopedic injuries: Presentation with a bone fracture, but without&#xD;
             any suspicion of any TBI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unknown time of trauma (uncertainty more than 1 hour).&#xD;
&#xD;
          -  More than 4 hours from the injury.&#xD;
&#xD;
          -  Known or suspected pre-existing neurological condition that can cause the observed&#xD;
             symptoms&#xD;
&#xD;
          -  For women of child-bearing age: known to be or suspected to be pregnant.&#xD;
&#xD;
          -  History of seizures within the last three months.&#xD;
&#xD;
          -  History of infection with HIV or hepatitis B, or diagnosed to be positive in the&#xD;
             concomitant screening.&#xD;
&#xD;
          -  Patients where the presence of TBI cannot be assessed reliably because of alcohol or&#xD;
             drugs, especially current use of anti-psychotic or anxiolytic medication.&#xD;
&#xD;
          -  History of stroke within three months.&#xD;
&#xD;
          -  The subject has a chronic neurodegenerative, metabolic (e.g. diabetes), or an&#xD;
             autoimmune disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mårten Kvist, MD/PhD</last_name>
    <role>Study Director</role>
    <affiliation>Medicortex Finland Oy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Satakunta Central Hospital</name>
      <address>
        <city>Pori</city>
        <zip>28500</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital (Tyks)</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vaasa Central Hospital</name>
      <address>
        <city>Vaasa</city>
        <zip>65130</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TBI</keyword>
  <keyword>Mild traumatic brain injury</keyword>
  <keyword>Concussion</keyword>
  <keyword>Diagnostics</keyword>
  <keyword>Rapid test</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>mTBI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will not be shared with other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306563
org study id: T213/2017
nct id: NCT03306563
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to confirm the clinical relevance of the novel biomarker for
      traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected
      from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c)
      healthy controls. The sponsor will do biochemical investigations for the samples to evaluate
      the presence, level and structure of the targeted biomarker.
The study will analyze and compare the levels of certain biomolecules and cellular
      degradation products which are released upon a brain injury and which become detectable in
      the body fluids. Patients with a traumatic brain injury are supposed to express these
      biomarkers in their body fluids while orthopedic trauma patients and healthy controls are
      supposed to be undetectable with respect to these biomolecules. The study is a case-control
      study where the study subjects with a property (injured) are compared to subjects without the
      property (healthy). The brain injury patient group will consist of subjects who entered the
      Emergency Department of the hospital with a suspected TBI. The orthopedic patient group will
      consists of patients who were admitted with a bone fracture in the limbs, but without a
      suspected TBI. The control group will consist of healthy subjects who will be recruited to
      the study by the activities of the study personnel.

      The entire study is split into two successive parts. In the first Part I, 18 - 24 subjects
      will be recruited in each group. In the second part, the number of the patients with
      suspected TBI will be added to up to 100 in order to receive an adequate number of samples
      and to gain sufficient statistical significance between the brain injury severities and in
      successive sampling time points.

      The collected samples and relevant clinical data of each subject will be supplied to the
      sponsor who will perform to the samples 1) Biochemical analysis for the presence and level of
      the biomarker, and 2) Biomarker profiling and structure analysis by LC/MS.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Total of 160 patients Phase 2a, 60 patients divided in three groups with TBI, orthopedic injury, and healthy volunteers (controls).
Phase 2b: 100 patients with concussion and mild traumatic brain injury.
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: Analytical evaluation and testing laboratories will get the samples blinded (coded).
measure: Biomarker level
time frame: One year (1 year)
description: Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).
arm group label: Patients with suspected TBI
arm group type: Experimental
description: The group will consist of patients who have arrived in the hospital with head injury and suspected isolated TBI. Sample collection (up to five times) and assessment of neurological status.
arm group label: Orthopedic patients
arm group type: Active Comparator
description: The group will consist of patients with orthopedic injury, but without a head injury and suspected TBI. Sample collection (once).
arm group label: Controls
arm group type: Sham Comparator
description: The group will consist of healthy controls who do not have a recent trauma history. Sample collection (once).
intervention type: Diagnostic Test
intervention name: Sample collection
description: Samples of blood, urine and saliva will be collected at up to five successive time points.
arm group label: Controls
arm group label: Orthopedic patients
arm group label: Patients with suspected TBI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mårten Kvist, MD/PhD
role: Study Director
affiliation: Medicortex Finland Oy
facility: 
facility: 
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries
mesh term: Fractures, Bone
sharing ipd: No
ipd description: Data will not be shared with other researchers.