<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/NCT01689077</url>
  </required_header>
  <id_info>
    <org_study_id>TTH48</org_study_id>
    <nct_id>NCT01689077</nct_id>
  </id_info>
  <brief_title>Time-differentiated Therapeutic Hypothermia</brief_title>
  <acronym>TTH48</acronym>
  <official_title>Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia&#xD;
      following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours&#xD;
      therapeutic hypothermia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However,&#xD;
      in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in&#xD;
      comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance&#xD;
      Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however&#xD;
      not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In&#xD;
      newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is&#xD;
      therefore relevant to investigate the influence of the treatment time on the cerebral outcome&#xD;
      in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia&#xD;
      (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome&#xD;
      after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score&#xD;
      measured 6 month after the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CPC</measure>
    <time_frame>6 month</time_frame>
    <description>CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>10 days</time_frame>
    <description>Adverse events are registered during the treatment and until discharge from primary hospital unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CPC at discharge</measure>
    <time_frame>3 month</time_frame>
    <description>CPC at discharge from primary hospital unit and after 28 days plus after 3 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>6 month</time_frame>
    <description>CPC 5 at 6 month</description>
  </secondary_outcome>
  <other_outcome>
    <measure>GCS</measure>
    <time_frame>28 days</time_frame>
    <description>Glasgow Coma Score at day 4 and at discharge from primary hospital unit</description>
  </other_outcome>
  <other_outcome>
    <measure>GCS progression</measure>
    <time_frame>25 weeks</time_frame>
    <description>Glasgow Coma Score throughout the observation period</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">355</enrollment>
  <condition>Out of Hospital Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>24 hours hypothermia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>24 hours hypothermia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>48 hours hypothermoa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>48 hours hypothermia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic hypothermia</intervention_name>
    <description>Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours</description>
    <arm_group_label>24 hours hypothermia</arm_group_label>
    <arm_group_label>48 hours hypothermoa</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Out of hospital cardiac arrest of suspected cardiac origin&#xD;
&#xD;
          2. Return of spontaneous circulation (ROSC)&#xD;
&#xD;
          3. Glasgow Coma Score &lt; 8&#xD;
&#xD;
          4. Estimated time interval from cardiac arrest to ROSC ≤ 60 min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. OOH-CA of suspected origin other than cardiac&#xD;
&#xD;
          2. In hospital Cardiac arrest&#xD;
&#xD;
          3. Terminal disease&#xD;
&#xD;
          4. Coagulation disorders&#xD;
&#xD;
          5. Unwitnessed asystolia&#xD;
&#xD;
          6. Time from cardiac arrest to start of hypothermia treatment &gt; 240 min&#xD;
&#xD;
          7. GCS ≥ 8&#xD;
&#xD;
          8. Pregnancy&#xD;
&#xD;
          9. Persistent cardiogenic shock (Systolic blood pressure &lt; 80 mmHg despite inotropic&#xD;
             treatment and aortic balloon pump).&#xD;
&#xD;
         10. CPC 3-4 before cardiac arrest&#xD;
&#xD;
         11. Acute intra cerebral bleeding&#xD;
&#xD;
         12. Acute stroke&#xD;
&#xD;
         13. Acute coronary artery bypass grafting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hans Kirkegaard, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesia and Intensive care medicine, Aarhus University Hosptal, Brendstrupgaardsvej 8200 Aarhus, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Intensive Care, Erasme Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department og Anesthesiologi and Intensive Care Medicine,</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology, Copenhagen University Hospital, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaesthesiology Clinic, North Estonia Medical Centre</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Anaesthesiology and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029-HUS</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital District of Southwest Finland), Kiinamyllynkatu</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Internal Medicine, Nephrology and Intensive Care; Charité-Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anesthesiology and Critical Care, Stavanger University Hospital</name>
      <address>
        <city>Stavanger</city>
        <zip>4068</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Norway</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <mesh_term>Hypothermia</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/NCT01689077
org study id: TTH48
nct id: NCT01689077
lead sponsor: 
has dmc: No
The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia
      following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours
      therapeutic hypothermia.
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However,
      in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in
      comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance
      Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however
      not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In
      newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is
      therefore relevant to investigate the influence of the treatment time on the cerebral outcome
      in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia
      (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome
      after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score
      measured 6 month after the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: CPC
time frame: 6 month
description: CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA.
measure: Adverse events
time frame: 10 days
description: Adverse events are registered during the treatment and until discharge from primary hospital unit
measure: CPC at discharge
time frame: 3 month
description: CPC at discharge from primary hospital unit and after 28 days plus after 3 month
measure: Mortality
time frame: 6 month
description: CPC 5 at 6 month
measure: GCS
time frame: 28 days
description: Glasgow Coma Score at day 4 and at discharge from primary hospital unit
measure: GCS progression
time frame: 25 weeks
description: Glasgow Coma Score throughout the observation period
arm group label: 24 hours hypothermia
arm group type: Active Comparator
description: 24 hours hypothermia
arm group label: 48 hours hypothermoa
arm group type: Experimental
description: 48 hours hypothermia
intervention type: Other
intervention name: Therapeutic hypothermia
description: Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours
arm group label: 24 hours hypothermia
arm group label: 48 hours hypothermoa
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hans Kirkegaard, Professor
role: Principal Investigator
affiliation: Department of Anaesthesia and Intensive care medicine, Aarhus University Hosptal, Brendstrupgaardsvej 8200 Aarhus, Denmark
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Denmark
country: Estonia
country: Finland
country: Germany
country: Norway
responsible party type: Sponsor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
mesh term: Hypothermia