<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/NCT02216513</url>
  </required_header>
  <id_info>
    <org_study_id>2014P001400</org_study_id>
    <nct_id>NCT02216513</nct_id>
  </id_info>
  <brief_title>Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage</brief_title>
  <official_title>Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dr. Jeffrey Thomas Stroke Shield Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will test the central hypothesis that DFO treatment after SAH may improve&#xD;
      cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective&#xD;
      neuroprotectant against delayed ischemic injury after SAH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principle Investigator is moving to another institution and plans to restart this proctocol in&#xD;
    the new location.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Early Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>delayed cerebral ischemia (DCI)</measure>
    <time_frame>6 weeks post hemorrhage</time_frame>
    <description>DCI will be defined radiographically as any cerebral infarct on the latest CT scan that was seen within 6 weeks after SAH or before discharge or death, that was not present on admission scan or on the CT scan done within 24 to 48 hours after any aneurysmal treatment procedures. All head CT scans will be reviewed for DCI ascertainment by neuroradiologists blinded to the clinical and TCD data using the standardized protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome at discharge</measure>
    <time_frame>patient's discharge date, which averages 3-4 weeks post hemorrhage</time_frame>
    <description>Clinical outcome at discharge will be assessed using modified Rankin Scale (mRS) as a global functional status. The modified Rankin scale evaluates global disability and handicap; scores range from 0 (no symptoms or disability) to 6 (death). Good mRS will be defined as score of ≤ 2.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cerebrovascular function (i.e., cerebral autoregulation)</measure>
    <time_frame>5 days after initiation of study drug</time_frame>
    <description>Spectral analysis of the relationship between arterial pressure and blood flow velocity in the bilateral middle cerebral arteries (measured via TCD). Autoregulation will be assessed from the phase and gain of the transfer function. Phase shift reflects the temporal difference between cerebral flow velocity fluctuations with respect to arterial pressure fluctuations. When the fluctuations of both flow and pressure are almost synchronous, the phase shift approaches zero, reflecting impaired cerebral autoregulation. Transfer function gain reflects the magnitude of transmission of arterial pressure fluctuations to cerebral blood flow velocity fluctuations. Lower gain, particularly in the low frequency (&lt; 0.1 Hz) range, is reflective of more effective cerebral autoregulation. Coherence reflects the degree of linear dependence between pressure and flow fluctuations. Thus, it provides a measure of validity of the metrics (gain and phase) derived from the linear transfer function.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Subarachnoid Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Desferrioxamine (DFO)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal saline IV for 4 hours for 5 consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>desferrioxamine (DFO)</intervention_name>
    <description>DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days</description>
    <arm_group_label>Desferrioxamine (DFO)</arm_group_label>
    <other_name>deferoxamine, desferal, DFO, deferoxamine mesylate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>normal saline IV for 4 hours for 5 consecutive days</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>normal saline NS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of spontaneous SAH&#xD;
&#xD;
          -  impaired cerebral autoregulation on day 2-4 post SAH&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  traumatic SAH&#xD;
&#xD;
          -  other central neurological disorders such as tumors, known prior stroke, hemorrhage or&#xD;
             vascular malformations&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  severe renal disease or anuria&#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>Farzaneh A Sorond, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>July 17, 2015</last_update_submitted>
  <last_update_submitted_qc>July 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Farzaneh Sorond</investigator_full_name>
    <investigator_title>BWPO Physician</investigator_title>
  </responsible_party>
  <keyword>subarachnoid hemorrhage</keyword>
  <keyword>SAH</keyword>
  <keyword>DFO</keyword>
  <keyword>cerebral autoregulation</keyword>
  <keyword>delayed cerebral ischemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deferoxamine</mesh_term>
  </intervention_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/NCT02216513
org study id: 2014P001400
nct id: NCT02216513
lead sponsor: 
collaborator: 
has dmc: No
The investigators will test the central hypothesis that DFO treatment after SAH may improve
      cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective
      neuroprotectant against delayed ischemic injury after SAH.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: delayed cerebral ischemia (DCI)
time frame: 6 weeks post hemorrhage
description: DCI will be defined radiographically as any cerebral infarct on the latest CT scan that was seen within 6 weeks after SAH or before discharge or death, that was not present on admission scan or on the CT scan done within 24 to 48 hours after any aneurysmal treatment procedures. All head CT scans will be reviewed for DCI ascertainment by neuroradiologists blinded to the clinical and TCD data using the standardized protocol.
measure: Clinical outcome at discharge
time frame: patient's discharge date, which averages 3-4 weeks post hemorrhage
description: Clinical outcome at discharge will be assessed using modified Rankin Scale (mRS) as a global functional status. The modified Rankin scale evaluates global disability and handicap; scores range from 0 (no symptoms or disability) to 6 (death). Good mRS will be defined as score of ≤ 2.
measure: Cerebrovascular function (i.e., cerebral autoregulation)
time frame: 5 days after initiation of study drug
description: Spectral analysis of the relationship between arterial pressure and blood flow velocity in the bilateral middle cerebral arteries (measured via TCD). Autoregulation will be assessed from the phase and gain of the transfer function. Phase shift reflects the temporal difference between cerebral flow velocity fluctuations with respect to arterial pressure fluctuations. When the fluctuations of both flow and pressure are almost synchronous, the phase shift approaches zero, reflecting impaired cerebral autoregulation. Transfer function gain reflects the magnitude of transmission of arterial pressure fluctuations to cerebral blood flow velocity fluctuations. Lower gain, particularly in the low frequency (< 0.1 Hz) range, is reflective of more effective cerebral autoregulation. Coherence reflects the degree of linear dependence between pressure and flow fluctuations. Thus, it provides a measure of validity of the metrics (gain and phase) derived from the linear transfer function.
arm group label: Desferrioxamine (DFO)
arm group type: Active Comparator
description: DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days
arm group label: placebo
arm group type: Placebo Comparator
description: normal saline IV for 4 hours for 5 consecutive days
intervention type: Drug
intervention name: desferrioxamine (DFO)
description: DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days
arm group label: Desferrioxamine (DFO)
other name: deferoxamine, desferal, DFO, deferoxamine mesylate
intervention type: Drug
intervention name: placebo
description: normal saline IV for 4 hours for 5 consecutive days
arm group label: placebo
other name: normal saline NS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Farzaneh A Sorond, MD, PhD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Farzaneh Sorond
investigator title: BWPO Physician
mesh term: Subarachnoid Hemorrhage
mesh term: Brain Ischemia
mesh term: Cerebral Infarction
mesh term: Hemorrhage
mesh term: Ischemia
mesh term: Deferoxamine