<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/NCT01708642</url>
  </required_header>
  <id_info>
    <org_study_id>RH-4074-OJ2</org_study_id>
    <secondary_id>2012-002889-12</secondary_id>
    <nct_id>NCT01708642</nct_id>
  </id_info>
  <brief_title>The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery</brief_title>
  <official_title>The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of intraoperative administration of&#xD;
      low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hip arthroplasty is associated with bleeding, anemia and the need for allogeneic transfusion.&#xD;
      Administration of low-dose adrenaline activates the coagulation system and may decrease&#xD;
      intraoperative and immediate postoperative bleeding. Thus, the aim of this study is to&#xD;
      evaluation whether intraoperative IV-administration of low-dose adrenaline reduces bleeding&#xD;
      in elective total hip arthroplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>End of surgery (last suture)</time_frame>
    <description>Intraoperative blood loss as estimated from surgical drain and sponges.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calculated blood loss</measure>
    <time_frame>24 hours after end of surgery.</time_frame>
    <description>Calculated blood loss at 24 h after end of surgery.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Drug side effects</measure>
    <time_frame>During surgery (from start of procedure to last suture)</time_frame>
    <description>Side effects causing discontinuation the study drug.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Intraoperative Blood Loss</condition>
  <arm_group>
    <arm_group_label>Adrenaline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoperative low-dose adrenaline infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo: Isotonic Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adrenaline</intervention_name>
    <description>Adrenaline infusion 0.05 microgram / kg / minute</description>
    <arm_group_label>Adrenaline</arm_group_label>
    <other_name>Ephinephrine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intraoperative isotonic saline infusion as placebo for adrenaline.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years.&#xD;
&#xD;
          -  Scheduled for primary unilateral hip arthroplasty&#xD;
&#xD;
          -  Able to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy towards adrenaline&#xD;
&#xD;
          -  Current treatment with: ADP receptor inhibitors or Vitamin K antagonists (within 5&#xD;
             days), Factor Xa inhibitors or Thrombin inhibitors (within 1 day), heparin (excluding&#xD;
             low molecular weight heparin for perioperative thromboprophylaxis).&#xD;
&#xD;
          -  Current treatment with tricyclic antidepressants&#xD;
&#xD;
          -  Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days).&#xD;
&#xD;
          -  Acute coronary syndrome / myocardial infarction within the previous 6 months.&#xD;
&#xD;
          -  not willing to accept blood transfusion&#xD;
&#xD;
          -  Participation in other clinical trial within previous 30 days&#xD;
&#xD;
          -  Women of childbearing age (without menopause for at least 12 months)&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Pheochromocytoma&#xD;
&#xD;
          -  Low serum K+ (&lt; 3.0 mmol/L)&#xD;
&#xD;
          -  Thyrotoxicosis&#xD;
&#xD;
          -  Digoxin intoxication&#xD;
&#xD;
          -  Alcohol og drug abuse (investigators judgement)&#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>Pär I Johanssion, M.D., DMsc.</last_name>
    <role>Study Chair</role>
    <affiliation>Rigshospitalet, Section for transfusion medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Oeivind Jans, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Section for Surgical Pathophysiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gentofte Hospital, Department of Anaesthesia</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hvidovre Hospital, Department of orthopaedic surgery</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Sygehus, Department of orthopedic surgery</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>February 16, 2015</last_update_submitted>
  <last_update_submitted_qc>February 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Oeivind Jans</investigator_full_name>
    <investigator_title>M.D, Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Epinephryl borate</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/NCT01708642
org study id: RH-4074-OJ2
secondary id: 2012-002889-12
nct id: NCT01708642
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of intraoperative administration of
      low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.
Hip arthroplasty is associated with bleeding, anemia and the need for allogeneic transfusion.
      Administration of low-dose adrenaline activates the coagulation system and may decrease
      intraoperative and immediate postoperative bleeding. Thus, the aim of this study is to
      evaluation whether intraoperative IV-administration of low-dose adrenaline reduces bleeding
      in elective total hip arthroplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Intraoperative blood loss
time frame: End of surgery (last suture)
description: Intraoperative blood loss as estimated from surgical drain and sponges.
measure: Calculated blood loss
time frame: 24 hours after end of surgery.
description: Calculated blood loss at 24 h after end of surgery.
measure: Drug side effects
time frame: During surgery (from start of procedure to last suture)
description: Side effects causing discontinuation the study drug.
arm group label: Adrenaline
arm group type: Experimental
description: Intraoperative low-dose adrenaline infusion
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo: Isotonic Saline
intervention type: Drug
intervention name: Adrenaline
description: Adrenaline infusion 0.05 microgram / kg / minute
arm group label: Adrenaline
other name: Ephinephrine
intervention type: Drug
intervention name: Placebo
description: Intraoperative isotonic saline infusion as placebo for adrenaline.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pär I Johanssion, M.D., DMsc.
role: Study Chair
affiliation: Rigshospitalet, Section for transfusion medicine
last name: Oeivind Jans, M.D.
role: Principal Investigator
affiliation: Rigshospitalet, Section for Surgical Pathophysiology
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Oeivind Jans
investigator title: M.D, Research Fellow
mesh term: Hemorrhage
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Epinephryl borate