<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/NCT03826004</url>
  </required_header>
  <id_info>
    <org_study_id>Clemastine Pilot Study</org_study_id>
    <nct_id>NCT03826004</nct_id>
  </id_info>
  <brief_title>Clemastine in Cardiovascular Surgery</brief_title>
  <official_title>Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</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>
      In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the&#xD;
      effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in&#xD;
      cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on&#xD;
      reducing heparin and protamine associated anaphylaxis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the&#xD;
      effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in&#xD;
      cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on&#xD;
      reducing heparin and protamine associated anaphylaxis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Histamine concentration in plasma</measure>
    <time_frame>Perioperative period</time_frame>
    <description>Plasma histamine concentration evaluated by ELISA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Perioperative period</time_frame>
    <description>Invasive blood pressure of radial artery: systolic, diastolic and mean pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway pressure</measure>
    <time_frame>Perioperative period</time_frame>
    <description>Airway pressure: peak and plat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin manifestation</measure>
    <time_frame>Perioperative period</time_frame>
    <description>Rate of skin manifestations, including wheal, papules, maculopapules, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrhythmia</measure>
    <time_frame>Perioperative period</time_frame>
    <description>Rate of perioperative arrhythmia, especially tachycardia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific symptoms</measure>
    <time_frame>Perioperative period</time_frame>
    <description>Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Efficacy and Safety</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline solution 2ml before anesthetic induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clemastine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clemastine fumarate 2mg/2ml before anesthetic induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clemastine</intervention_name>
    <description>Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle</description>
    <arm_group_label>Clemastine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Solution</intervention_name>
    <description>Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-75 years old&#xD;
&#xD;
          -  Receiving selective cardiovascular surgery with cardiopulmonary bypass due to&#xD;
             coronary, valvular or congenital heart disease&#xD;
&#xD;
          -  Written informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of cardiac surgery&#xD;
&#xD;
          -  Allergy to clemastine, antihistamines with similar chemical structure or any excipient&#xD;
             (sorbitol, sodium citrate, propylene glycol, ethanol)&#xD;
&#xD;
          -  Myasthenia gravis&#xD;
&#xD;
          -  Porphyria patients&#xD;
&#xD;
          -  Bronchial asthma&#xD;
&#xD;
          -  Usage of monoamine oxidase (MAO) inhibitors&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Mentally or legally disabled patients&#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_official>
    <last_name>Jia Shi, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Cardiovascular Institute and Fuwai Hospital, CAMS&amp;PUMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiovascular Institute and Fuwai Hospital, CAMS&amp;PUMC</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>SHI Jia</investigator_full_name>
    <investigator_title>Assoticate Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiovascular Surgery</keyword>
  <keyword>Histamine H1 Receptor Antagonist</keyword>
  <keyword>Anaphylaxis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clemastine</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/NCT03826004
org study id: Clemastine Pilot Study
nct id: NCT03826004
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the
      effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in
      cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on
      reducing heparin and protamine associated anaphylaxis.
In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the
      effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in
      cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on
      reducing heparin and protamine associated anaphylaxis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Histamine concentration in plasma
time frame: Perioperative period
description: Plasma histamine concentration evaluated by ELISA
measure: Blood pressure
time frame: Perioperative period
description: Invasive blood pressure of radial artery: systolic, diastolic and mean pressure
measure: Airway pressure
time frame: Perioperative period
description: Airway pressure: peak and plat
measure: Skin manifestation
time frame: Perioperative period
description: Rate of skin manifestations, including wheal, papules, maculopapules, etc
measure: Arrhythmia
time frame: Perioperative period
description: Rate of perioperative arrhythmia, especially tachycardia
measure: Specific symptoms
time frame: Perioperative period
description: Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline solution 2ml before anesthetic induction
arm group label: Clemastine
arm group type: Experimental
description: Clemastine fumarate 2mg/2ml before anesthetic induction
intervention type: Drug
intervention name: Clemastine
description: Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle
arm group label: Clemastine
intervention type: Drug
intervention name: Saline Solution
description: Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jia Shi, M.D.
role: Study Chair
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: SHI Jia
investigator title: Assoticate Professor
mesh term: Clemastine