<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/NCT03287557</url>
  </required_header>
  <id_info>
    <org_study_id>17-0583-F6A</org_study_id>
    <nct_id>NCT03287557</nct_id>
  </id_info>
  <brief_title>Dysregulated CNS Inflammation After Acute Brain Injury</brief_title>
  <official_title>Dysregulated CNS Inflammation After Acute Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      By doing this study, the investigator hopes to learn how the levels of important proteins&#xD;
      involved in inflammation change over time in patients with acute brain injury. The total&#xD;
      amount of time participants will be asked to volunteer for this study is approximately two&#xD;
      hours over a five day period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot project is a prospective, observational study in 20 patients who are admitted to&#xD;
      University of Kentucky (UK) Chandler Medical Center with a diagnosis of severe,&#xD;
      non-penetrating traumatic brain injury (TBI) or aneurysmal subarachnoid hemorrhage (aSAH).&#xD;
&#xD;
      All adult participants with a primary diagnosis of severe, non-penetrating TBI or aSAH who&#xD;
      are admitted to the neuroscience or trauma intensive care units will be screened for&#xD;
      potential inclusion into this study. Once a potential participant is identified, the&#xD;
      legally-authorized representative will be approached for study consent and HIPAA&#xD;
      authorization. If the participant regains consent capacity before the end of the&#xD;
      cerebrospinal fluid (CSF) collection period, assent will be obtained from the research&#xD;
      participant.&#xD;
&#xD;
      In this research study, up to 5 small samples of CSF, will be carefully removed from the&#xD;
      device, already in place, that drains excess CSF from the participant's head. The samples&#xD;
      will be less than 1 teaspoon (&lt; 5 mL) each. These samples will be frozen and stored until&#xD;
      samples from approximately 20 participants have been obtained.&#xD;
&#xD;
      These samples will then be prepared and sent to a research laboratory to analyze the proteins&#xD;
      in the samples collected from each research participant.&#xD;
&#xD;
      Because the results of this study will not affect the treatment participants receive in or&#xD;
      outside of the hospital, the investigator will not share the results of this study with the&#xD;
      participant, their doctor or their family member(s).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">May 24, 2019</completion_date>
  <primary_completion_date type="Actual">May 24, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Severe TBI - Measure of temporal profile of inflammatory proteins in CSF</measure>
    <time_frame>For 24 months from start of the study</time_frame>
    <description>CSF collection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>aSAH - Measure of temporal profile of inflammatory proteins in CSF</measure>
    <time_frame>For 24 months from start of the study</time_frame>
    <description>CSF collection</description>
  </secondary_outcome>
  <enrollment type="Actual">8</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Aneurysmal Subarachnoid Hemorrhage</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      CSF will be collected from an external ventricular drain (EVD) at five time points&#xD;
      post-injury: 6, 12, 24, 48, 60 hrs&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants selected will come from those who have been admitted to the University of&#xD;
        Kentucky (UK) medical center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severe, non-penetrating TBI or aSAH&#xD;
&#xD;
          -  must have a ventriculostomy (EVD) placed by the UK Neurosurgery service within 12&#xD;
             hours of primary traumatic episode&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-survivable brain injury or other organ system injury&#xD;
&#xD;
          -  life expectancy is five days or less&#xD;
&#xD;
          -  penetrating TBI&#xD;
&#xD;
          -  status epilepticus upon arrival to the hospital&#xD;
&#xD;
          -  severe ischemic heart disease or congestive heart failure, myocardial infarction, or&#xD;
             spinal cord injury&#xD;
&#xD;
          -  Takotsubo cardiomyopathy secondary to the SAH&#xD;
&#xD;
          -  active cancer or have been treated for cancer within the previous 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>101 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda J Van Eldik, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536-0298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Linda Van Eldik</investigator_full_name>
    <investigator_title>Sponsor Investigator</investigator_title>
  </responsible_party>
  <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>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03287557
org study id: 17-0583-F6A
nct id: NCT03287557
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
By doing this study, the investigator hopes to learn how the levels of important proteins
      involved in inflammation change over time in patients with acute brain injury. The total
      amount of time participants will be asked to volunteer for this study is approximately two
      hours over a five day period.
This pilot project is a prospective, observational study in 20 patients who are admitted to
      University of Kentucky (UK) Chandler Medical Center with a diagnosis of severe,
      non-penetrating traumatic brain injury (TBI) or aneurysmal subarachnoid hemorrhage (aSAH).

      All adult participants with a primary diagnosis of severe, non-penetrating TBI or aSAH who
      are admitted to the neuroscience or trauma intensive care units will be screened for
      potential inclusion into this study. Once a potential participant is identified, the
      legally-authorized representative will be approached for study consent and HIPAA
      authorization. If the participant regains consent capacity before the end of the
      cerebrospinal fluid (CSF) collection period, assent will be obtained from the research
      participant.

      In this research study, up to 5 small samples of CSF, will be carefully removed from the
      device, already in place, that drains excess CSF from the participant's head. The samples
      will be less than 1 teaspoon (< 5 mL) each. These samples will be frozen and stored until
      samples from approximately 20 participants have been obtained.

      These samples will then be prepared and sent to a research laboratory to analyze the proteins
      in the samples collected from each research participant.

      Because the results of this study will not affect the treatment participants receive in or
      outside of the hospital, the investigator will not share the results of this study with the
      participant, their doctor or their family member(s).
observational model: Case-Only
time perspective: Prospective
measure: Severe TBI - Measure of temporal profile of inflammatory proteins in CSF
time frame: For 24 months from start of the study
description: CSF collection
measure: aSAH - Measure of temporal profile of inflammatory proteins in CSF
time frame: For 24 months from start of the study
description: CSF collection
CSF will be collected from an external ventricular drain (EVD) at five time points
      post-injury: 6, 12, 24, 48, 60 hrs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 101 Years
healthy volunteers: No
last name: Linda J Van Eldik, PhD
role: Study Director
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kentucky
investigator full name: Linda Van Eldik
investigator title: Sponsor Investigator
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Subarachnoid Hemorrhage
mesh term: Inflammation
mesh term: Hemorrhage
mesh term: Wounds and Injuries
sharing ipd: No