<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/NCT01731444</url>
  </required_header>
  <id_info>
    <org_study_id>PhenylephrineRCT</org_study_id>
    <nct_id>NCT01731444</nct_id>
  </id_info>
  <brief_title>Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury</brief_title>
  <official_title>Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The standard of care for treatment of burn injury is to inject a solution of epinephrine&#xD;
      under the skin of the injured site in order to reduce blood loss during skin grafting. This&#xD;
      solution of epinephrine has been shown to have effects on the body outside the donor site.&#xD;
      Some people have increases in heart rate and blood pressure. We will study the effect of a&#xD;
      phenylephrine solution in place of an epinephrine solution to control blood loss. We think&#xD;
      that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.&#xD;
&#xD;
      The injured area will be injected under the skin and a skin graft will be taken in the same&#xD;
      way as we usually do. The only change will be the use of phenylephrine in the solution&#xD;
      instead of epinephrine.&#xD;
&#xD;
      Our goal is to find whether or not phenylephrine or epinephrine solution results in a&#xD;
      reduction of blood loss without affecting the rest of the body.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean arterial blood pressure (MAP)</measure>
    <time_frame>during first 30 minutes</time_frame>
    <description>Mean arterial blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>q15 min</time_frame>
    <description>Cut off for safety: Diastolic &gt;140 or Systolic &gt;180;&#xD;
Recorded:&#xD;
just prior to induction of anesthesia&#xD;
maximum heart rate during time of procedure&#xD;
minimum heart rate during time of procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>q15 min</time_frame>
    <description>Recorded:&#xD;
just prior to induction of anesthesia&#xD;
maximum heart rate during time of procedure&#xD;
minimum heart rate during time of procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <arm_group>
    <arm_group_label>Phenylephrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 ug/cc</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1:1000000</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <arm_group_label>Epinephrine</arm_group_label>
    <arm_group_label>Phenylephrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        a) Burn injury requiring debridement and grafting between 5-30% TBSA&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Head and neck, hand, foot, or genital burns&#xD;
&#xD;
          2. On anticoagulants (except NSAIDs)&#xD;
&#xD;
          3. On monoamine oxidase inhibitor or tricyclic antidepressant&#xD;
&#xD;
          4. Coronary or peripheral vascular disease&#xD;
&#xD;
          5. History of arrhythmias&#xD;
&#xD;
          6. On a Beta-blocker&#xD;
&#xD;
          7. History of vascular abnormality&#xD;
&#xD;
          8. Hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Justin Gawaziuk, MSc</last_name>
    <phone>2047873669</phone>
    <email>jgawaziuk@hsc.mb.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin P Gawaziuk, MSc</last_name>
      <phone>2047873669</phone>
      <email>jgawaziuk@hsc.mb.ca</email>
    </contact>
    <investigator>
      <last_name>Sarvesh Logsetty, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>blood loss</keyword>
  <keyword>burn</keyword>
  <keyword>hemostasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Blood Loss, Surgical</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</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/NCT01731444
org study id: PhenylephrineRCT
nct id: NCT01731444
lead sponsor: 
has dmc: Yes
The standard of care for treatment of burn injury is to inject a solution of epinephrine
      under the skin of the injured site in order to reduce blood loss during skin grafting. This
      solution of epinephrine has been shown to have effects on the body outside the donor site.
      Some people have increases in heart rate and blood pressure. We will study the effect of a
      phenylephrine solution in place of an epinephrine solution to control blood loss. We think
      that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.

      The injured area will be injected under the skin and a skin graft will be taken in the same
      way as we usually do. The only change will be the use of phenylephrine in the solution
      instead of epinephrine.

      Our goal is to find whether or not phenylephrine or epinephrine solution results in a
      reduction of blood loss without affecting the rest of the body.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean arterial blood pressure (MAP)
time frame: during first 30 minutes
description: Mean arterial blood pressure
measure: Blood Pressure
time frame: q15 min
description: Cut off for safety: Diastolic >140 or Systolic >180;
Recorded:
just prior to induction of anesthesia
maximum heart rate during time of procedure
minimum heart rate during time of procedure
measure: Heart Rate
time frame: q15 min
description: Recorded:
just prior to induction of anesthesia
maximum heart rate during time of procedure
minimum heart rate during time of procedure
arm group label: Phenylephrine
arm group type: Experimental
description: 20 ug/cc
arm group label: Epinephrine
arm group type: Active Comparator
description: 1:1000000
intervention type: Drug
intervention name: Phenylephrine
arm group label: Epinephrine
arm group label: Phenylephrine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Justin Gawaziuk, MSc
phone: 2047873669
email: jgawaziuk@hsc.mb.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Phenylephrine
mesh term: Oxymetazoline