<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/NCT02258360</url>
  </required_header>
  <id_info>
    <org_study_id>PROID7005</org_study_id>
    <nct_id>NCT02258360</nct_id>
  </id_info>
  <brief_title>Hypothermia and Hemostasis After Cardiac Arrest</brief_title>
  <official_title>The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <brief_summary>
    <textblock>
      This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48,&#xD;
      ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic&#xD;
      hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac&#xD;
      arrest.&#xD;
&#xD;
      The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after&#xD;
      cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia&#xD;
&#xD;
      Our specific aims are:&#xD;
&#xD;
        -  To investigate the whole blood coagulation using the rotational thromboelastometry.&#xD;
&#xD;
        -  To investigate the function of platelets&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clotting time in seconds, EXTEM</measure>
    <time_frame>After 46 hours</time_frame>
    <description>Measured by thomboelastometry on the ROTEM®</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve, COL-test</measure>
    <time_frame>After 46 hours</time_frame>
    <description>Platelet function will be measured using Multiplate®</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clotting time in seconds, EXTEM</measure>
    <time_frame>After 22 hours and 70 hours</time_frame>
    <description>Measured by thomboelastometry on the ROTEM®.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clotting time in seconds, -INTEM, FIBTEM and HEPTEM</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
    <description>Measured by thomboelastometry on the ROTEM®.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
    <description>Measured by thomboelastometry on the ROTEM®.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
    <description>Measured by thomboelastometry on the ROTEM®.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve, COL-test</measure>
    <time_frame>After 22 hours and 70 hours</time_frame>
    <description>Platelet function will be measured using Multiplate®.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve,- ADP, ASPI and TRAP-test.</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
    <description>Platelet function will be measured using Multiplate®.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
    <description>Measured by thomboelastometry on the ROTEM®.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
    <description>Measured by thomboelastometry on the ROTEM®.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve, Clot stability test</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve, Thrombin generation</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>International normalized ratio</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>APTT (activated partial thromboplastin time) in seconds</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fibrinogen in mol/l</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Antithrombin in 10^3 int.units/l</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>D-dimer in mg/l FEU</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Trombine time in seconds</measure>
    <time_frame>After 22 hours, 46 hours and 70 hours</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Hypothermia</condition>
  <condition>Heart Arrest</condition>
  <condition>Hemostasis</condition>
  <condition>Coagulants</condition>
  <arm_group>
    <arm_group_label>24 hours hypothermia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Therapeutic hypothermia for 24 hours after reaching target temperature</description>
  </arm_group>
  <arm_group>
    <arm_group_label>48 hours hypothermia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapeutic hypothermia for 48 hours after reaching target temperature</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic hypothermia</intervention_name>
    <description>Therapeutic hypothermia with a target temperature between 32-34°C.</description>
    <arm_group_label>24 hours hypothermia</arm_group_label>
    <arm_group_label>48 hours hypothermia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Out of hospital cardiac arrest of presumed cardiac cause&#xD;
&#xD;
          -  Return of spontaneous circulation (ROSC)&#xD;
&#xD;
          -  Glasgow Coma Score &lt; 8&#xD;
&#xD;
          -  Age &gt; 18 years and &lt; 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt; 60 minutes from the circulatory collapse to ROSC&#xD;
&#xD;
          -  Time interval &gt; 4 hours from cardiac arrest to initiation of therapeutic hypothermia&#xD;
&#xD;
          -  Terminal illness&#xD;
&#xD;
          -  Coagulation disorder&#xD;
&#xD;
          -  Unwitnessed asystolia&#xD;
&#xD;
          -  Cerebral performance category 3-4 before the cardiac arrest&#xD;
&#xD;
          -  Severe persistent cardiogenic shock&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Persistent cardiogenic shock (systolic blood pressure &lt; 80 despite inotropic&#xD;
             treatment)&#xD;
&#xD;
          -  New apoplexy or intracerebral hemorrhage&#xD;
&#xD;
          -  Lack of consent from the relatives&#xD;
&#xD;
          -  Lack of consent from the GP&#xD;
&#xD;
          -  Lack of consent from the patient if he/she wakes up and is relevant&#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>Anni Norgaard Jeppesen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby</name>
      <address>
        <city>Aarhus</city>
        <state>Aarhus N</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>March 28, 2016</last_update_submitted>
  <last_update_submitted_qc>March 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thromboelastometry</keyword>
  <keyword>Haemostasis</keyword>
  <keyword>Hypothermia</keyword>
  <keyword>Heart Arrest</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart 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/NCT02258360
org study id: PROID7005
nct id: NCT02258360
lead sponsor: 
This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48,
      ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic
      hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac
      arrest.

      The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after
      cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia

      Our specific aims are:

        -  To investigate the whole blood coagulation using the rotational thromboelastometry.

        -  To investigate the function of platelets
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clotting time in seconds, EXTEM
time frame: After 46 hours
description: Measured by thomboelastometry on the ROTEM®
measure: Area under the curve, COL-test
time frame: After 46 hours
description: Platelet function will be measured using Multiplate®
measure: Clotting time in seconds, EXTEM
time frame: After 22 hours and 70 hours
description: Measured by thomboelastometry on the ROTEM®.
measure: Clotting time in seconds, -INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
description: Measured by thomboelastometry on the ROTEM®.
measure: Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
description: Measured by thomboelastometry on the ROTEM®.
measure: Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
description: Measured by thomboelastometry on the ROTEM®.
measure: Area under the curve, COL-test
time frame: After 22 hours and 70 hours
description: Platelet function will be measured using Multiplate®.
measure: Area under the curve,- ADP, ASPI and TRAP-test.
time frame: After 22 hours, 46 hours and 70 hours
description: Platelet function will be measured using Multiplate®.
measure: Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
description: Measured by thomboelastometry on the ROTEM®.
measure: Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
description: Measured by thomboelastometry on the ROTEM®.
measure: Area under the curve, Clot stability test
time frame: After 22 hours, 46 hours and 70 hours
measure: Area under the curve, Thrombin generation
time frame: After 22 hours, 46 hours and 70 hours
measure: International normalized ratio
time frame: After 22 hours, 46 hours and 70 hours
measure: APTT (activated partial thromboplastin time) in seconds
time frame: After 22 hours, 46 hours and 70 hours
measure: Fibrinogen in mol/l
time frame: After 22 hours, 46 hours and 70 hours
measure: Antithrombin in 10^3 int.units/l
time frame: After 22 hours, 46 hours and 70 hours
measure: D-dimer in mg/l FEU
time frame: After 22 hours, 46 hours and 70 hours
measure: Trombine time in seconds
time frame: After 22 hours, 46 hours and 70 hours
arm group label: 24 hours hypothermia
arm group type: Active Comparator
description: Therapeutic hypothermia for 24 hours after reaching target temperature
arm group label: 48 hours hypothermia
arm group type: Experimental
description: Therapeutic hypothermia for 48 hours after reaching target temperature
intervention type: Other
intervention name: Therapeutic hypothermia
description: Therapeutic hypothermia with a target temperature between 32-34°C.
arm group label: 24 hours hypothermia
arm group label: 48 hours hypothermia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anni Norgaard Jeppesen, MD
role: Principal Investigator
affiliation: Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Heart Arrest
mesh term: Hypothermia