<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/NCT02985060</url>
  </required_header>
  <id_info>
    <org_study_id>HELMET ver1.1</org_study_id>
    <nct_id>NCT02985060</nct_id>
  </id_info>
  <brief_title>Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke</brief_title>
  <acronym>HELMET</acronym>
  <official_title>Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke; Prospective, Open, Randomized, Multicenter Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bard Medical Division C.R. Bard Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study safety and feasibility of mild therapeutic hypothermia after successful&#xD;
      recanalization by mechanical endovascular treatment in patients with acute ischemic stroke&#xD;
      and proximal arterial occlusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current clinical trial is an investigator-initiated one, and it is conducted under the&#xD;
      multi-center, randomized, open-label, prospective design. The subjects meeting&#xD;
      inclusion/exclusion criteria will be assigned to the treatment group or the control group.&#xD;
      The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day&#xD;
      hypothermia therapy followed by the process of recovery of temperature within 30 hours (the&#xD;
      recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is&#xD;
      followed by the closure of the clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>Favorable outcome</measure>
    <time_frame>3 months after symptom onset</time_frame>
    <description>modified Rankin Scale of 0-2 points at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mortality at 3 months</measure>
    <time_frame>3 months after symptom onset</time_frame>
    <description>mortality at 3 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvements in neurological functions</measure>
    <time_frame>Volume change on diffusion lesion at 5~7 days</time_frame>
    <description>Changes in the cerebral infarction lesions at 5~7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic cerebral hemorrhage</measure>
    <time_frame>within 5~7 days of symptom onset</time_frame>
    <description>deterioration in the National Institute of Health Stroke Scale score of ≥4 points with parenchymal hematoma type 2 documented by CT or MR image</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Thrombolytic Therapy</condition>
  <arm_group>
    <arm_group_label>Therapeutic hypothermia group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Stroke care based on international guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arctic Sun</intervention_name>
    <description>Induction phase: At a temperature of 4℃, a saline 500 mL or 1 L is intravenously administered.&#xD;
Arctic sun (surface freezing equipment) Target temperature: 35±0.5℃ Within 12 hours of the onset of symptoms, the therapeutic hypothermia is performed&#xD;
Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours&#xD;
Recovery phase:Rewarming velocity: 0.05~0.1℃ (within 30 hours)</description>
    <arm_group_label>Therapeutic hypothermia group</arm_group_label>
    <other_name>Therapeutic hypothermia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard treatment</intervention_name>
    <description>All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines.&#xD;
In all the patients, neurological assessments and NIHSS scoring are performed on a daily basis for 4 days with the help of board-certified nurses or specialists in stroke.&#xD;
Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days.&#xD;
Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <arm_group_label>Therapeutic hypothermia group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who submitted a written informed consent prior to the participation in the&#xD;
             current clinical trial (If the subjects have conditions that they cannot decide on&#xD;
             study participation according to their own will, they would participate in the study&#xD;
             after their legal representatives submitted a written informed consent form. During&#xD;
             the period of study participation, if patients' medical conditions are improved, the&#xD;
             written informed consent should be submitted again.)&#xD;
&#xD;
          2. Patients with ischemic stroke attributed to carotid artery or middle cerebral artery&#xD;
             occlusion achieved successful recanalization (TICI 2b or 3) immediately after&#xD;
             endovascular treatment within 8 hours of symptom onset: Onset time was defined as the&#xD;
             time when patients were lastly seen normal.&#xD;
&#xD;
          3. Patients of both sexes aged between 18 and 80 years old&#xD;
&#xD;
          4. NIHSS scores of 6-25 points at screening&#xD;
&#xD;
          5. mRS 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g.,&#xD;
             those with middle cerebral or internal carotid artery)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No evaluation for cranial artery before endovascular treatment&#xD;
&#xD;
          2. Patient with emergent stenting insertion in intracranial or extracranial artery&#xD;
&#xD;
          3. Transient ischemic attack or lacunar infarction&#xD;
&#xD;
          4. Platelet counts &lt; 75,000/mm3&#xD;
&#xD;
          5. coagulopathy (INR spontaneously &gt;1.5)&#xD;
&#xD;
          6. Hemodynamic instability&#xD;
&#xD;
          7. acute myocardial infarction, acute unstable angina or severe cardiac failure (NYHA&#xD;
             classification ≥III)&#xD;
&#xD;
          8. Sepsis&#xD;
&#xD;
          9. Pregnant or breastfeeding women&#xD;
&#xD;
         10. Premorbid modified Rankin Scale Scores of &gt; 2 points&#xD;
&#xD;
         11. Hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine&#xD;
&#xD;
         12. Intracranial hemorrhage or hemorrhagic transformation in initial CT scan&#xD;
&#xD;
         13. Brain tumor or CNS infection&#xD;
&#xD;
         14. Patients who participated in other clinical trials within 3 months&#xD;
&#xD;
         15. Life expectancy within 1 year&#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>MOON-KU HAN, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>MOON-KU HAN, professor</last_name>
    <phone>82-31-787-7464</phone>
    <email>mkhan@snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Bundang</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeoinggido</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MOON-KU HAN, professor</last_name>
      <phone>82-31-787-7464</phone>
      <email>mkhan@snu.ac.kr</email>
    </contact>
    <contact_backup>
      <last_name>JEONG-HO HONG, professor</last_name>
      <phone>82-53-250-7317</phone>
      <email>neurohong79@mail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Moon Ku Han</investigator_full_name>
    <investigator_title>proffessor</investigator_title>
  </responsible_party>
  <keyword>Therapeutic hypothermia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</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/NCT02985060
org study id: HELMET ver1.1
nct id: NCT02985060
lead sponsor: 
collaborator: 
has dmc: No
To study safety and feasibility of mild therapeutic hypothermia after successful
      recanalization by mechanical endovascular treatment in patients with acute ischemic stroke
      and proximal arterial occlusion.
The current clinical trial is an investigator-initiated one, and it is conducted under the
      multi-center, randomized, open-label, prospective design. The subjects meeting
      inclusion/exclusion criteria will be assigned to the treatment group or the control group.
      The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day
      hypothermia therapy followed by the process of recovery of temperature within 30 hours (the
      recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is
      followed by the closure of the clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Favorable outcome
time frame: 3 months after symptom onset
description: modified Rankin Scale of 0-2 points at 3 months
measure: mortality at 3 months
time frame: 3 months after symptom onset
description: mortality at 3 months
measure: Improvements in neurological functions
time frame: Volume change on diffusion lesion at 5~7 days
description: Changes in the cerebral infarction lesions at 5~7 days
measure: Symptomatic cerebral hemorrhage
time frame: within 5~7 days of symptom onset
description: deterioration in the National Institute of Health Stroke Scale score of ≥4 points with parenchymal hematoma type 2 documented by CT or MR image
arm group label: Therapeutic hypothermia group
arm group type: Experimental
description: Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)
arm group label: Control group
arm group type: Other
description: Stroke care based on international guidelines
intervention type: Device
intervention name: Arctic Sun
description: Induction phase: At a temperature of 4℃, a saline 500 mL or 1 L is intravenously administered.
Arctic sun (surface freezing equipment) Target temperature: 35±0.5℃ Within 12 hours of the onset of symptoms, the therapeutic hypothermia is performed
Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours
Recovery phase:Rewarming velocity: 0.05~0.1℃ (within 30 hours)
arm group label: Therapeutic hypothermia group
other name: Therapeutic hypothermia
intervention type: Other
intervention name: Standard treatment
description: All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines.
In all the patients, neurological assessments and NIHSS scoring are performed on a daily basis for 4 days with the help of board-certified nurses or specialists in stroke.
Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days.
Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days.
arm group label: Control group
intervention type: Drug
intervention name: Saline
arm group label: Therapeutic hypothermia group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: MOON-KU HAN, professor
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: MOON-KU HAN, professor
phone: 82-31-787-7464
email: mkhan@snu.ac.kr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Moon Ku Han
investigator title: proffessor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
mesh term: Hypothermia