<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/NCT02222597</url>
  </required_header>
  <id_info>
    <org_study_id>201209046DPB</org_study_id>
    <nct_id>NCT02222597</nct_id>
  </id_info>
  <brief_title>An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.</brief_title>
  <official_title>An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma&#xD;
      detection of head trauma patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <primary_completion_date type="Anticipated">December 2014</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>detect the predictive value of the infrascanner for intracranial hemorrhage</measure>
    <time_frame>within 12 hours after head injury</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Within 12 Hrs of Head Injury</condition>
  <arm_group>
    <arm_group_label>positive infrascanner finding</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>infrascanner</intervention_name>
    <arm_group_label>positive infrascanner finding</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients within 12 hours after head injury visit the Emergency Department of the NTUH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The patients within 12 hours after head injury, visiting the Emergency Department of the&#xD;
        National Taiwan University Hospital, and receiving computed tomography of head were&#xD;
        enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients over 12 hours after head injury, visiting the Emergency Department of the&#xD;
             NTUH, and receiving computed tomography of head were excluded.&#xD;
&#xD;
          2. Patients with massive scalp laceration or hematoma were excluded. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Meng-Che Wu, MD</last_name>
    <phone>+886-972653208</phone>
    <email>mengcher111@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cheng-Yi Wu, MD</last_name>
    <phone>+886-972653218</phone>
    <email>alanwuem@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital Emergency Department</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meng-che Wu, MD</last_name>
      <phone>+886-972653208</phone>
      <email>mengcher111@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 24, 2014</last_update_submitted>
  <last_update_submitted_qc>August 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>head injury</keyword>
  <keyword>infrascanner</keyword>
  <keyword>intracranial hemorrhage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Hematoma</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/NCT02222597
org study id: 201209046DPB
nct id: NCT02222597
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma
      detection of head trauma patients
observational model: Cohort
time perspective: Prospective
measure: detect the predictive value of the infrascanner for intracranial hemorrhage
time frame: within 12 hours after head injury
arm group label: positive infrascanner finding
intervention type: Device
intervention name: infrascanner
arm group label: positive infrascanner finding
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Meng-Che Wu, MD
phone: +886-972653208
email: mengcher111@gmail.com
last name: Cheng-Yi Wu, MD
phone: +886-972653218
email: alanwuem@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Craniocerebral Trauma
mesh term: Emergencies
mesh term: Hematoma