<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/NCT03270683</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3047_DOTAC</org_study_id>
    <nct_id>NCT03270683</nct_id>
  </id_info>
  <brief_title>Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest</brief_title>
  <acronym>DOTAC</acronym>
  <official_title>Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest: the DOTAC Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography&#xD;
      (TCD) in comatose survivors after cardiac arrest.&#xD;
&#xD;
      Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit&#xD;
      and cardiac intensive care unit in a university hospital.&#xD;
&#xD;
      Patients: all comatose patients older than 18 years successfully resuscitated from an&#xD;
      out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic&#xD;
      brain injury, no window for TCD measurements, or dead before neurological prognostication are&#xD;
      excluded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators measure the pulsatility index (PI) and diastolic flow velocity (DFV) of the&#xD;
      right and left middle cerebral artery during the first 12 h after return of spontaneous&#xD;
      circulation (ROSC). The highest value of DFV and the lowest of PI will use for the&#xD;
      statistical analysis. Cerebral Performance Category evaluate neurologic outcome at hospital&#xD;
      discharge.&#xD;
&#xD;
      Data provided by early TCD after ROSC are associated with neurological outcome. The use of&#xD;
      these data could lead to the development of therapeutics improving cerebral perfusion in&#xD;
      patient resuscitated from an OHCA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the relation between TCD measurements and neurologic outcome at hospital discharge</measure>
    <time_frame>6 months</time_frame>
    <description>Good score = CPC 1-2 and bad score = CPC 3-5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of pulsatility index</measure>
    <time_frame>12 hours</time_frame>
    <description>Evaluate the association between pulsatility index and period of cardiac arrest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Entry of doppler parameters</measure>
    <time_frame>6 months</time_frame>
    <description>Identify a doppler parameter than can improve the neurological outcome</description>
  </secondary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>Cardiac Arrest</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients resuscitated from out-of-hospital cardiac arrest&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older 18 years&#xD;
&#xD;
          -  out-of-hospital cardiac arrest with recovery of spontaneous cardiac activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  transcranial doppler not done or not interpretable&#xD;
&#xD;
          -  associated cranial trauma&#xD;
&#xD;
          -  died without neurological assessment&#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>Adel Maamar, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>December 26, 2019</last_update_submitted>
  <last_update_submitted_qc>December 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Out-of-hospital cardiac arrest</keyword>
  <keyword>transcranial Doppler sonography</keyword>
  <keyword>cerebrovascular circulation</keyword>
  <keyword>prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</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/NCT03270683
org study id: 35RC16_3047_DOTAC
nct id: NCT03270683
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography
      (TCD) in comatose survivors after cardiac arrest.

      Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit
      and cardiac intensive care unit in a university hospital.

      Patients: all comatose patients older than 18 years successfully resuscitated from an
      out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic
      brain injury, no window for TCD measurements, or dead before neurological prognostication are
      excluded.
The investigators measure the pulsatility index (PI) and diastolic flow velocity (DFV) of the
      right and left middle cerebral artery during the first 12 h after return of spontaneous
      circulation (ROSC). The highest value of DFV and the lowest of PI will use for the
      statistical analysis. Cerebral Performance Category evaluate neurologic outcome at hospital
      discharge.

      Data provided by early TCD after ROSC are associated with neurological outcome. The use of
      these data could lead to the development of therapeutics improving cerebral perfusion in
      patient resuscitated from an OHCA.
observational model: Case-Control
time perspective: Prospective
measure: Evaluate the relation between TCD measurements and neurologic outcome at hospital discharge
time frame: 6 months
description: Good score = CPC 1-2 and bad score = CPC 3-5
measure: Measurement of pulsatility index
time frame: 12 hours
description: Evaluate the association between pulsatility index and period of cardiac arrest
measure: Entry of doppler parameters
time frame: 6 months
description: Identify a doppler parameter than can improve the neurological outcome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adel Maamar, Dr
role: Principal Investigator
affiliation: CHU Rennes
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest