<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/NCT02991690</url>
  </required_header>
  <id_info>
    <org_study_id>20160758</org_study_id>
    <secondary_id>CDMRP-AR150187</secondary_id>
    <secondary_id>20160365</secondary_id>
    <nct_id>NCT02991690</nct_id>
  </id_info>
  <brief_title>Systemic Hypothermia in Acute Cervical Spinal Cord Injury</brief_title>
  <official_title>Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is a prospective multi-center trial designed to determine the safety profile and&#xD;
      efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8)&#xD;
      Spinal Cord Injury (SCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the proposed clinical trial is to demonstrate the safety and efficacy of&#xD;
      intravascular hypothermia as part of the early hospital management and treatment for acute&#xD;
      cervical SCI. Each year in the US, there are over 11,000 new cases of para- and quadriplegia&#xD;
      and 100,000 new cases of partial but permanent neurological losses due to acute SCI. Thus the&#xD;
      potential for clinical hypothermia following SCI to improve neurological outcome has&#xD;
      significant value. Many patients suffering SCI become permanently dependent on caretakers and&#xD;
      become a financial liability to both the family and society. Hypothermia has the potential to&#xD;
      improve outcome so that more patients suffering SCI can regain independent motor and sensory&#xD;
      function and remain economically productive members of society. The use of modest hypothermia&#xD;
      through intravascular cooling may ultimately lead to better care of the patient with acute&#xD;
      SCI and may also have more widespread uses in patients presenting with stroke or cardiac&#xD;
      arrest. In the long-term, this research may lend support to the use of hypothermia that could&#xD;
      in turn save money for the patients, hospitals, the government and society as a whole.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 4, 2017</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</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>Neurological improvement on American Spinal Injury Association (ASIA)</measure>
    <time_frame>Between baseline and 12 months</time_frame>
    <description>Improvement in ASIA Impairment Scale (AIS) after modest hypothermia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurological improvement on ASIA</measure>
    <time_frame>Between baseline and 12 months</time_frame>
    <description>Improvement in ASIA motor score after modest hypothermia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional improvement in Functional Independence Measure (FIM)</measure>
    <time_frame>12 months</time_frame>
    <description>Functional improvement in FIM after modest hypothermia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional improvement in Spinal Cord Independence Measure (SCIM)</measure>
    <time_frame>12 months</time_frame>
    <description>Functional improvement in SCIM after modest hypothermia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Spinal Cord Injury, Acute</condition>
  <arm_group>
    <arm_group_label>Hypothermia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care medical treatment, specific to each individual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypothermia</intervention_name>
    <description>To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification [510(k), K030421]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC/hr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC/hr. until normothermia (T 37ºC) is achieved.</description>
    <arm_group_label>Hypothermia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 - 70 years of age&#xD;
&#xD;
          -  AIS Grade A - C&#xD;
&#xD;
          -  Glasgow Coma Scale ≥14&#xD;
&#xD;
          -  Able to start hypothermia treatment within 24 hours of injury&#xD;
&#xD;
          -  Non-penetrating injury. Patients urgently taken to the operating room for surgical&#xD;
             reduction may also be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 70 years&#xD;
&#xD;
          -  AIS Grade D&#xD;
&#xD;
          -  Hyperthermia on admission (&gt;38.5ºC)&#xD;
&#xD;
          -  Severe systemic injury&#xD;
&#xD;
          -  Severe bleeding&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Thrombocytopenia&#xD;
&#xD;
          -  Known prior severe cardiac history&#xD;
&#xD;
          -  Blood dyscrasia&#xD;
&#xD;
          -  Pancreatitis&#xD;
&#xD;
          -  Reynaud's syndrome&#xD;
&#xD;
          -  Cord transection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allan D Levi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>George Jimsheleishvili, MD</last_name>
    <phone>305-243-4781</phone>
    <email>gxj150@miami.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>HonorHealth Research Institute with Barrow Brain and Spine</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Camille Fajardo, CCRC</last_name>
      <phone>623-879-1692</phone>
      <email>cafajardo@honorhealth.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jackson Memorial Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>George Jimsheleishvili, MD</last_name>
      <phone>305-243-4781</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303-3049</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Faiz Ahmad, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202-1000</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of Maryland School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leslie Sult, BSN, RN</last_name>
      <phone>410-328-3657</phone>
      <email>lsult@som.umaryland.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107-5125</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Harrop, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Prisma Health - University of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paisley Myers, PhD</last_name>
      <phone>803-296-9274</phone>
      <email>paisley.myers@prismahealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Levi AD, Casella G, Green BA, Dietrich WD, Vanni S, Jagid J, Wang MY. Clinical outcomes using modest intravascular hypothermia after acute cervical spinal cord injury. Neurosurgery. 2010 Apr;66(4):670-7. doi: 10.1227/01.NEU.0000367557.77973.5F.</citation>
    <PMID>20190669</PMID>
  </reference>
  <reference>
    <citation>Dididze M, Green BA, Dietrich WD, Vanni S, Wang MY, Levi AD. Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study. Spinal Cord. 2013 May;51(5):395-400. doi: 10.1038/sc.2012.161. Epub 2012 Dec 18.</citation>
    <PMID>23247015</PMID>
  </reference>
  <reference>
    <citation>Levi AD, Green BA, Wang MY, Dietrich WD, Brindle T, Vanni S, Casella G, Elhammady G, Jagid J. Clinical application of modest hypothermia after spinal cord injury. J Neurotrauma. 2009 Mar;26(3):407-15. doi: 10.1089/neu.2008.0745.</citation>
    <PMID>19271964</PMID>
  </reference>
  <reference>
    <citation>Vedantam A, Jimsheleishvili G, Harrop JS, Alberga LR, Ahmad FU, Murphy RK, Jackson JB 3rd, Rodgers RB, Levi AD. A prospective multi-center study comparing the complication profile of modest systemic hypothermia versus normothermia for acute cervical spinal cord injury. Spinal Cord. 2022 Jun;60(6):510-515. doi: 10.1038/s41393-021-00747-w. Epub 2022 Jan 10.</citation>
    <PMID>35013548</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Allan D. Levi</investigator_full_name>
    <investigator_title>Professor and Chairman of Neurological Surgery</investigator_title>
  </responsible_party>
  <keyword>Hypothermia</keyword>
  <keyword>Cervical Spinal Cord Injury</keyword>
  <keyword>Trauma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Hypothermia</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02991690
org study id: 20160758
secondary id: CDMRP-AR150187
secondary id: 20160365
nct id: NCT02991690
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a prospective multi-center trial designed to determine the safety profile and
      efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8)
      Spinal Cord Injury (SCI).
The purpose of the proposed clinical trial is to demonstrate the safety and efficacy of
      intravascular hypothermia as part of the early hospital management and treatment for acute
      cervical SCI. Each year in the US, there are over 11,000 new cases of para- and quadriplegia
      and 100,000 new cases of partial but permanent neurological losses due to acute SCI. Thus the
      potential for clinical hypothermia following SCI to improve neurological outcome has
      significant value. Many patients suffering SCI become permanently dependent on caretakers and
      become a financial liability to both the family and society. Hypothermia has the potential to
      improve outcome so that more patients suffering SCI can regain independent motor and sensory
      function and remain economically productive members of society. The use of modest hypothermia
      through intravascular cooling may ultimately lead to better care of the patient with acute
      SCI and may also have more widespread uses in patients presenting with stroke or cardiac
      arrest. In the long-term, this research may lend support to the use of hypothermia that could
      in turn save money for the patients, hospitals, the government and society as a whole.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Neurological improvement on American Spinal Injury Association (ASIA)
time frame: Between baseline and 12 months
description: Improvement in ASIA Impairment Scale (AIS) after modest hypothermia
measure: Neurological improvement on ASIA
time frame: Between baseline and 12 months
description: Improvement in ASIA motor score after modest hypothermia
measure: Functional improvement in Functional Independence Measure (FIM)
time frame: 12 months
description: Functional improvement in FIM after modest hypothermia
measure: Functional improvement in Spinal Cord Independence Measure (SCIM)
time frame: 12 months
description: Functional improvement in SCIM after modest hypothermia
arm group label: Hypothermia
arm group type: Experimental
description: Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.
arm group label: Control
arm group type: No Intervention
description: Standard of care medical treatment, specific to each individual.
intervention type: Other
intervention name: Hypothermia
description: To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification [510(k), K030421]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC/hr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC/hr. until normothermia (T 37ºC) is achieved.
arm group label: Hypothermia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Allan D Levi, MD, PhD
role: Principal Investigator
affiliation: University of Miami
last name: George Jimsheleishvili, MD
phone: 305-243-4781
email: gxj150@miami.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
citation: Levi AD, Casella G, Green BA, Dietrich WD, Vanni S, Jagid J, Wang MY. Clinical outcomes using modest intravascular hypothermia after acute cervical spinal cord injury. Neurosurgery. 2010 Apr;66(4):670-7. doi: 10.1227/01.NEU.0000367557.77973.5F.
PMID: 20190669
citation: Dididze M, Green BA, Dietrich WD, Vanni S, Wang MY, Levi AD. Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study. Spinal Cord. 2013 May;51(5):395-400. doi: 10.1038/sc.2012.161. Epub 2012 Dec 18.
PMID: 23247015
citation: Levi AD, Green BA, Wang MY, Dietrich WD, Brindle T, Vanni S, Casella G, Elhammady G, Jagid J. Clinical application of modest hypothermia after spinal cord injury. J Neurotrauma. 2009 Mar;26(3):407-15. doi: 10.1089/neu.2008.0745.
PMID: 19271964
citation: Vedantam A, Jimsheleishvili G, Harrop JS, Alberga LR, Ahmad FU, Murphy RK, Jackson JB 3rd, Rodgers RB, Levi AD. A prospective multi-center study comparing the complication profile of modest systemic hypothermia versus normothermia for acute cervical spinal cord injury. Spinal Cord. 2022 Jun;60(6):510-515. doi: 10.1038/s41393-021-00747-w. Epub 2022 Jan 10.
PMID: 35013548
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Allan D. Levi
investigator title: Professor and Chairman of Neurological Surgery
mesh term: Spinal Cord Injuries
mesh term: Hypothermia
mesh term: Wounds and Injuries
sharing ipd: No