<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/NCT01669408</url>
  </required_header>
  <id_info>
    <org_study_id>PreCOOL 1</org_study_id>
    <nct_id>NCT01669408</nct_id>
  </id_info>
  <brief_title>Prehospital COOLing 1 (PreCOOL 1)</brief_title>
  <acronym>PreCOOL</acronym>
  <official_title>A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Heidelberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Heidelberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elevated body temperature was shown to be associated with worse outcome in acute stroke&#xD;
      patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital&#xD;
      cooling with cold infusions in stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>Phase 2</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>Tympanic Temperature</measure>
    <time_frame>from randomization (prehospital) until arrival in the ER, an expected average of 45min</time_frame>
    <description>Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>single measurement at arrival in the ER</time_frame>
    <description>Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital parameters</measure>
    <time_frame>from randomization (prehospital) until arrival in the ER, an expected average of 45min</time_frame>
    <description>Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability</measure>
    <time_frame>from randomization (prehospital) until arrival in the ER, an expected average of 45min</time_frame>
    <description>Tolerability outcome measures include the Bedside Shivering Assessment Scale (BSAS) and a 10 point visual analog scale to assess &quot;feeling cold&quot; and &quot;shivering&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min</time_frame>
    <description>Safety outcome measures include the analysis of (severe) adverse events (e.g. bleeding complications, cardiac decompensation), dose of co-medication needed (e.g. antihypertensives, diuretics, anti-shivering medication), number of patients with oral temperature &lt; 36°C and safety laboratory (Na, K, creatinine, urea, GFR, CK, CK-MB, troponin T, glucose, blood count, INR, aPTT, TT, NT-ProBNP and D-dimer)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Cold infusions</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infusion of 1L cold crystalloid solution (4°C) over 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Best medical treatment following international stroke guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cold crystalloid infusions, 0.9%NaCl or Ringer's solution</intervention_name>
    <description>Infusion of 1L cold crystalloid solution (4°C) over 15 minutes</description>
    <arm_group_label>Cold infusions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected stroke&#xD;
&#xD;
          -  Symptom onset ≤ 7 days&#xD;
&#xD;
          -  Tympanic temperature ≥ 36.7°C&#xD;
&#xD;
          -  Informed consent by the patient&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiac insufficiency (NYHA ≥ III)&#xD;
&#xD;
          -  New anisocoria, severe nausea, vomiting or headache&#xD;
&#xD;
          -  High-grade heart valve stenosis or insufficiency&#xD;
&#xD;
          -  Acute pulmonary embolism&#xD;
&#xD;
          -  Acute myocardial infarction&#xD;
&#xD;
          -  Threatening ventricular dysrhythmia&#xD;
&#xD;
          -  Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia,&#xD;
             cold agglutinins, sickle cell anemia)&#xD;
&#xD;
          -  Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis&#xD;
             obliterans)&#xD;
&#xD;
          -  Severe renal insufficiency with reduced diuresis&#xD;
&#xD;
          -  Pregnancy&#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>Sven Poli, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Heidelberg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Erik Popp, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Heidelberg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sven Poli, Dr. med.</last_name>
    <phone>0049 6221 56</phone>
    <phone_ext>0</phone_ext>
    <email>sven.poli@med.uni-heidelberg.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erik Popp, PD Dr. med.</last_name>
    <phone>0049 6221 56</phone>
    <phone_ext>0</phone_ext>
    <email>erik.popp@med.uni-heidelberg.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sven Poli, Dr. med.</last_name>
      <phone>0049 6221 56</phone>
      <phone_ext>0</phone_ext>
      <email>sven.poli@med.uni-heidelberg.de</email>
    </contact>
    <contact_backup>
      <last_name>Erik Popp, PD Dr. med.</last_name>
      <phone>0049 6221 56</phone>
      <phone_ext>0</phone_ext>
      <email>erik.popp@med.uni-heidelberg.de</email>
    </contact_backup>
    <investigator>
      <last_name>Sven Poli, Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Erik Popp, PD Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian Hametner, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jan Purrucker, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Miriam Priglinger, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maxim Bartz</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>June 21, 2013</last_update_submitted>
  <last_update_submitted_qc>June 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
    <investigator_full_name>Dr. Sven Poli</investigator_full_name>
    <investigator_title>Dr. Sven Poli, Consultant Neurologist, Principical Investigator</investigator_title>
  </responsible_party>
  <keyword>ischemic stroke</keyword>
  <keyword>hemorrhagic stroke</keyword>
  <keyword>prehospital cooling</keyword>
  <keyword>induction of cooling</keyword>
  <keyword>ambulance</keyword>
  <keyword>emergency room</keyword>
  <keyword>cold infusions</keyword>
  <keyword>hypothermia</keyword>
  <keyword>normothermia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT01669408
org study id: PreCOOL 1
nct id: NCT01669408
lead sponsor: 
has dmc: No
Elevated body temperature was shown to be associated with worse outcome in acute stroke
      patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital
      cooling with cold infusions in stroke patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tympanic Temperature
time frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
description: Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.
measure: Efficacy
time frame: single measurement at arrival in the ER
description: Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.
measure: Vital parameters
time frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
description: Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.
measure: Tolerability
time frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
description: Tolerability outcome measures include the Bedside Shivering Assessment Scale (BSAS) and a 10 point visual analog scale to assess "feeling cold" and "shivering".
measure: Safety
time frame: from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min
description: Safety outcome measures include the analysis of (severe) adverse events (e.g. bleeding complications, cardiac decompensation), dose of co-medication needed (e.g. antihypertensives, diuretics, anti-shivering medication), number of patients with oral temperature < 36°C and safety laboratory (Na, K, creatinine, urea, GFR, CK, CK-MB, troponin T, glucose, blood count, INR, aPTT, TT, NT-ProBNP and D-dimer)
arm group label: Cold infusions
arm group type: Active Comparator
description: Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
arm group label: Control group
arm group type: No Intervention
description: Best medical treatment following international stroke guidelines
intervention type: Drug
intervention name: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
description: Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
arm group label: Cold infusions
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sven Poli, Dr. med.
role: Principal Investigator
affiliation: University Hospital Heidelberg
last name: Erik Popp, PD Dr. med.
role: Principal Investigator
affiliation: University Hospital Heidelberg
last name: Sven Poli, Dr. med.
phone: 0049 6221 56
phone ext: 0
email: sven.poli@med.uni-heidelberg.de
last name: Erik Popp, PD Dr. med.
phone: 0049 6221 56
phone ext: 0
email: erik.popp@med.uni-heidelberg.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Heidelberg
investigator full name: Dr. Sven Poli
investigator title: Dr. Sven Poli, Consultant Neurologist, Principical Investigator
mesh term: Stroke