<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/NCT02988102</url>
  </required_header>
  <id_info>
    <org_study_id>FKelmendi</org_study_id>
    <nct_id>NCT02988102</nct_id>
  </id_info>
  <brief_title>Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma</brief_title>
  <official_title>Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma Injury in Acute Phase in Relation to Head CT and Post Concusion Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Clinical Centre of Kosova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Clinical Centre of Kosova</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In pediatric age groups communication difficulties very sometimes may present further&#xD;
      obstacles in obtaining a detailed injury history and early identification of TBI symptoms.&#xD;
&#xD;
      Most emergency management protocols are focused exclusively on the identification of the&#xD;
      relatively small number of patients who may require operative intervention, as early surgery&#xD;
      is believed to improve outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      However early rehabilitation can also be effective for the much larger number of patients who&#xD;
      do not require surgery[1] In addition, Hall and others recently reported that low doses of&#xD;
      ionizing radiation to the brain in infancy may influence cognitive abilities in adulthood.&#xD;
      [2] Accordingly, increased serum concentrations of, for example S100B ( a calcium-binding&#xD;
      protein present in high concentrations in glial cells) and neurone-specific enolase ( NSE: a&#xD;
      cytoplasmatic enzyme occuring predominantly in neurones ) have been demonstrated to reflect&#xD;
      the presence and severity of brain tissue damage in acute head injuries. [3] In both&#xD;
      pediatric age and adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Role of concentration of biomarkers S100B and NSE in serum in mild and moderate head trauma injury in acute phase in relation to head CT and post concusion syndrome.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Biomarkers</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Following S100B and NSE in head trauma</intervention_name>
    <description>Following S100B and NSE in head trauma in correlation with Head CT and post concussion syndrome and Lisat11</description>
    <other_name>S100B NSE</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biomarkers S100B and NSE in blood sample ( Venous blood)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        2 groups pediatric and adult.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only head trauma without any other body injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fatos Kelmendi</last_name>
    <phone>+377 44 128 255</phone>
    <email>dr.kelmendifatos@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Agon Mekaj, PhD</last_name>
    <phone>+377 44 373545</phone>
    <email>dragonmekaj@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fatos Kelmendi</name>
      <address>
        <city>Tirana</city>
        <state>Kosovo Prishtina</state>
        <zip>10 000</zip>
        <country>Albania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agon Mekaj, PhD</last_name>
      <phone>+37744373545</phone>
      <email>dragonmekaj@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ridvan Alimehmeti, PhD</last_name>
      <phone>+355692102140</phone>
      <email>ridvanalimehmeti@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Albania</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Clinical Centre of Kosova</investigator_affiliation>
    <investigator_full_name>Dr. Fatos Kelmendi</investigator_full_name>
    <investigator_title>Dr. Fatos Kelmendi Neurosurgeon</investigator_title>
  </responsible_party>
  <keyword>S100B, NSE</keyword>
  <keyword>moderate brain trauma</keyword>
  <keyword>mild brain trauma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Craniocerebral Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02988102
org study id: FKelmendi
nct id: NCT02988102
lead sponsor: 
has dmc: Yes
In pediatric age groups communication difficulties very sometimes may present further
      obstacles in obtaining a detailed injury history and early identification of TBI symptoms.

      Most emergency management protocols are focused exclusively on the identification of the
      relatively small number of patients who may require operative intervention, as early surgery
      is believed to improve outcome.
However early rehabilitation can also be effective for the much larger number of patients who
      do not require surgery[1] In addition, Hall and others recently reported that low doses of
      ionizing radiation to the brain in infancy may influence cognitive abilities in adulthood.
      [2] Accordingly, increased serum concentrations of, for example S100B ( a calcium-binding
      protein present in high concentrations in glial cells) and neurone-specific enolase ( NSE: a
      cytoplasmatic enzyme occuring predominantly in neurones ) have been demonstrated to reflect
      the presence and severity of brain tissue damage in acute head injuries. [3] In both
      pediatric age and adults.
observational model: Cohort
time perspective: Prospective
measure: Role of concentration of biomarkers S100B and NSE in serum in mild and moderate head trauma injury in acute phase in relation to head CT and post concusion syndrome.
time frame: 2 years
intervention type: Other
intervention name: Following S100B and NSE in head trauma
description: Following S100B and NSE in head trauma in correlation with Head CT and post concussion syndrome and Lisat11
other name: S100B NSE
Biomarkers S100B and NSE in blood sample ( Venous blood)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fatos Kelmendi
phone: +377 44 128 255
email: dr.kelmendifatos@gmail.com
last name: Agon Mekaj, PhD
phone: +377 44 373545
email: dragonmekaj@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Albania
responsible party type: Principal Investigator
investigator affiliation: University Clinical Centre of Kosova
investigator full name: Dr. Fatos Kelmendi
investigator title: Dr. Fatos Kelmendi Neurosurgeon
mesh term: Craniocerebral Trauma
sharing ipd: No