<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/NCT01730443</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00014409a</org_study_id>
    <secondary_id>1R01NS071867</secondary_id>
    <nct_id>NCT01730443</nct_id>
  </id_info>
  <brief_title>Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury</brief_title>
  <acronym>BIO-ProTECT</acronym>
  <official_title>Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blood samples will be drawn on traumatic brain injury patients who are participating in the&#xD;
      ProTECT III study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blood samples will be drawn on traumatic brain injury patients who are participating in the&#xD;
      ProTECT III study just prior to the initiation of the study drug infusion and 24 and 48 hours&#xD;
      from the time they are enrolled in the study to test for biomarkers that may help predict how&#xD;
      severe the injury is and how well they improve. The investigators will also test to see if&#xD;
      the study medication is being absorbed and is staying at a consistent level in the blood&#xD;
      stream.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Parent trial (ProTECT III) stopped for futility&#xD;
  </why_stopped>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured.</measure>
    <time_frame>Baseline, 24 hours, 48 hours</time_frame>
    <description>Blood will be collected/processed at baseline, 24 hours and 48 hours.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">576</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>On progesterone treatment</arm_group_label>
    <description>The group assigned to progesterone treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group assigned to placebo</arm_group_label>
    <description>The group that will not be receiving progesterone treatment</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      with consent there will be long term storage of serum for Non-DNA testing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with a moderate to severe blunt traumatic brain injury who meet the inclusion and&#xD;
        exclusion criteria for the ProTECT III study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe brain injury (iGCS 12-4 or motor response 2-5 if intubated).&#xD;
&#xD;
          -  Age &gt;18 years (or developmental stage Tanner 5 in patients where age is not known)&#xD;
&#xD;
          -  Blunt, traumatic, closed head injury (altered mental status due to brain injury)&#xD;
&#xD;
          -  Able to initiate study drug infusion within 4 hours from time of injury -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-survivable injury as determined by treating&#xD;
&#xD;
          -  Bilateral dilated unresponsive pupils&#xD;
&#xD;
          -  Spinal cord injury with neurological deficits, pre-injury paralysis (quad/paraplegic)&#xD;
&#xD;
          -  Inability to perform activities of daily living (ADL) without assistance&#xD;
&#xD;
          -  Cardiopulmonary arrest&#xD;
&#xD;
          -  Status epilepticus on arrival or concern for post ictal state&#xD;
&#xD;
          -  systolic blood pressure &lt; 90 for two consecutive readings at least 5 minutes apart any&#xD;
             time prior to randomization&#xD;
&#xD;
          -  O2 Sat &lt; 90 for at least 5 consecutive minutes any time prior to randomization&#xD;
&#xD;
          -  Prisoner or ward of state&#xD;
&#xD;
          -  Known active breast or reproductive organ cancers (via medical records or family&#xD;
             interview)&#xD;
&#xD;
          -  Known allergy to progesterone or Intralipid components (egg yolk) (via medical records&#xD;
             or family interview)&#xD;
&#xD;
          -  Known history of blood clotting disorder (Protein S or C deficiency, etc.) or history&#xD;
             of pulmonary embolism (via medical records or family interview) or active/ongoing&#xD;
             thromboembolic event (myocardial infarction, ischemic stroke, pulmonary embolism, deep&#xD;
             vein thrombosis).&#xD;
&#xD;
          -  Blood or serum ethanol (EtOH) ≥ 250 mg %&#xD;
&#xD;
          -  Positive qualitative urine or serum pregnancy test&#xD;
&#xD;
          -  Concern for inability to follow up at 6 months (residence in foreign country, homeless&#xD;
             with limited contacts,&#xD;
&#xD;
          -  undocumented immigrants, or high likelihood of becoming incarcerated during study&#xD;
             period, etc.)&#xD;
&#xD;
          -  Patient in Opt Out registry or wearing Opt Out bracelet -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Frankel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Good Samaritan Health Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maricopa Integrated Health System</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scottsdale Healthcare</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco General Hospital</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Medical Ctr.-San Jose</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Clara Valley Medical Center</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Shock Trauma</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detroit Receiving</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Grace Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hurley Medical Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Health System</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Memorial Hospital</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Medical Center</name>
      <address>
        <city>St. Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Johns Mercy Medical Center</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYP Columbia</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health Sciences University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Lukes Hospital</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hahnemann University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Medical Center/Elvis Presley Memorial Trauma Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brackenridge Hospital</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78752</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froederdt Memorial Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 26, 2011</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Michael Frankel</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>traumatic brain injury</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>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT01730443
org study id: IRB00014409a
secondary id: 1R01NS071867
nct id: NCT01730443
lead sponsor: 
collaborator: 
has dmc: Yes
Blood samples will be drawn on traumatic brain injury patients who are participating in the
      ProTECT III study.
Blood samples will be drawn on traumatic brain injury patients who are participating in the
      ProTECT III study just prior to the initiation of the study drug infusion and 24 and 48 hours
      from the time they are enrolled in the study to test for biomarkers that may help predict how
      severe the injury is and how well they improve. The investigators will also test to see if
      the study medication is being absorbed and is staying at a consistent level in the blood
      stream.
observational model: Case-Only
time perspective: Prospective
measure: serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured.
time frame: Baseline, 24 hours, 48 hours
description: Blood will be collected/processed at baseline, 24 hours and 48 hours.
arm group label: On progesterone treatment
description: The group assigned to progesterone treatment.
arm group label: group assigned to placebo
description: The group that will not be receiving progesterone treatment
with consent there will be long term storage of serum for Non-DNA testing
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Frankel, MD
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Michael Frankel
investigator title: Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries