<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/NCT03229694</url>
  </required_header>
  <id_info>
    <org_study_id>XYFY-2017-068</org_study_id>
    <nct_id>NCT03229694</nct_id>
  </id_info>
  <brief_title>the Effect of Tracleer on Tourniquet-associated Hypertension</brief_title>
  <official_title>Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuzhou Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may&#xD;
      cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension.&#xD;
      Thus, to effectively prevent the tourniquet related hemodynamic responses is important for&#xD;
      patients receiving limb surgery.&#xD;
&#xD;
      Tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary&#xD;
      arterial hypertension. Tracleer can also be used to treat retistant hypertension. At present&#xD;
      trial, the investigators are going to investigate the effect of Tracleer on&#xD;
      tourniquet-associated hypertension during total knee arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At present study, the investigators will use endothelin receptor antagonist, Tracleer&#xD;
      (Bosentan), to investigate the effect of Tracleer on tourniquet-associated hypertension&#xD;
      during unilateral total knee arthroplasty, and evaluate its safety and effectivity. The&#xD;
      purpose of this study is to find a new therapy to prevent and treat tourniquet-associated&#xD;
      hypertension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2018</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum rate of change in systolic blood pressure (MR)</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine</measure>
    <time_frame>baseline and intraoperative</time_frame>
    <description>test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual analog scale</measure>
    <time_frame>24 hrs after surgery</time_frame>
    <description>assess the efficacy of analgesia using visual analog scale (VAS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Tourniquets</condition>
  <condition>Hypertension</condition>
  <condition>Bosentan</condition>
  <arm_group>
    <arm_group_label>Tracleer (or Bosentan)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo was administered orally at two hours before surgery and six hours after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tracleer 125Mg Tablet</intervention_name>
    <description>Tracleer was administered orally at two hours before surgery and six hours after surgery.</description>
    <arm_group_label>Tracleer (or Bosentan)</arm_group_label>
    <other_name>Bosentan</other_name>
    <other_name>endothelin receptor antagonist</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo was administered orally at two hour before surgery and six hours after surgery.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients underwent selected total knee arthroplasty under general anesthesia&#xD;
&#xD;
          -  ASA II-III&#xD;
&#xD;
          -  18~65 years old&#xD;
&#xD;
          -  Signed informed consent voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not apply tourniquet during the surgery&#xD;
&#xD;
          -  Patients underwent emergency surgery&#xD;
&#xD;
          -  Having applied tourniquet in last three months&#xD;
&#xD;
          -  Patients underwent bilateral total knee arthroplasty&#xD;
&#xD;
          -  Dysfunction of liver or kidney&#xD;
&#xD;
          -  Anemia (Hb &lt;90 g/L)&#xD;
&#xD;
          -  Serious myocardial disease (eg. coronary heart disease, heart failure, severe&#xD;
             arrhythmia)&#xD;
&#xD;
          -  Coagulation disorder&#xD;
&#xD;
          -  Diabetic&#xD;
&#xD;
          -  Leukocyte higher than normal value&#xD;
&#xD;
          -  Pneumonia, asthma, chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Hypotension before surgery (systolic pressure &lt; 90 mmHg)&#xD;
&#xD;
          -  Pregnant woman or puerpera&#xD;
&#xD;
          -  Having being enrolled in other clinical trial in last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Su Liu, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Affiliated Hospital of Xuzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiang Cao, professor</last_name>
    <phone>+86-516-85802291</phone>
    <email>xyfyll2297@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Affiliated Hospital of Xuzhou Medical University</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jiang Cao, doctor</last_name>
      <phone>+86-516-85802291</phone>
      <email>xyfyll2297@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 22, 2017</last_update_submitted>
  <last_update_submitted_qc>July 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xuzhou Medical University</investigator_affiliation>
    <investigator_full_name>Su Liu</investigator_full_name>
    <investigator_title>Associtate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bosentan</mesh_term>
    <mesh_term>Endothelin Receptor Antagonists</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03229694
org study id: XYFY-2017-068
nct id: NCT03229694
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may
      cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension.
      Thus, to effectively prevent the tourniquet related hemodynamic responses is important for
      patients receiving limb surgery.

      Tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary
      arterial hypertension. Tracleer can also be used to treat retistant hypertension. At present
      trial, the investigators are going to investigate the effect of Tracleer on
      tourniquet-associated hypertension during total knee arthroplasty.
At present study, the investigators will use endothelin receptor antagonist, Tracleer
      (Bosentan), to investigate the effect of Tracleer on tourniquet-associated hypertension
      during unilateral total knee arthroplasty, and evaluate its safety and effectivity. The
      purpose of this study is to find a new therapy to prevent and treat tourniquet-associated
      hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Maximum rate of change in systolic blood pressure (MR)
time frame: 24 hours after surgery
description: During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure
measure: the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine
time frame: baseline and intraoperative
description: test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point
measure: visual analog scale
time frame: 24 hrs after surgery
description: assess the efficacy of analgesia using visual analog scale (VAS)
arm group label: Tracleer (or Bosentan)
arm group type: Experimental
description: Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo was administered orally at two hours before surgery and six hours after surgery
intervention type: Drug
intervention name: Tracleer 125Mg Tablet
description: Tracleer was administered orally at two hours before surgery and six hours after surgery.
arm group label: Tracleer (or Bosentan)
other name: Bosentan
other name: endothelin receptor antagonist
intervention type: Drug
intervention name: Placebo
description: Placebo was administered orally at two hour before surgery and six hours after surgery.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Su Liu, doctor
role: Principal Investigator
affiliation: The Affiliated Hospital of Xuzhou Medical University
last name: Jiang Cao, professor
phone: +86-516-85802291
email: xyfyll2297@163.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xuzhou Medical University
investigator full name: Su Liu
investigator title: Associtate professor
mesh term: Hypertension
mesh term: Bosentan
mesh term: Endothelin Receptor Antagonists
sharing ipd: Undecided