<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/NCT01714297</url>
  </required_header>
  <id_info>
    <org_study_id>REK Sør-øst s-08012d</org_study_id>
    <nct_id>NCT01714297</nct_id>
  </id_info>
  <brief_title>Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)</brief_title>
  <official_title>A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Martina Hansen's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Martina Hansen's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if there are differences in clinical events, i.e&#xD;
      bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight&#xD;
      Heparin) is initiated before or after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">April 2009</completion_date>
  <primary_completion_date type="Actual">June 2008</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>total blood loss</measure>
    <time_frame>during and after surgery</time_frame>
    <description>measured blood loss during surgery and in wound drains</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>transfusion requirements</measure>
    <time_frame>during and after surgery</time_frame>
    <description>number of units packed red blood cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of bleeding events</measure>
    <time_frame>during and after surgery</time_frame>
    <description>excessive bleeding, wound hematoma, wound secretion, other bleeding events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>other complications</measure>
    <time_frame>during and after surgery</time_frame>
    <description>all other complications related to surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Arthritis of the Hip</condition>
  <condition>Transfusion Related Complications</condition>
  <condition>Infection</condition>
  <condition>Wound Discharge</condition>
  <arm_group>
    <arm_group_label>dalteparin 5000IU s.c.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Syringes of Saline with the same volume as in the dalteparin injections are injected the evenings before total hip arthroplasty. Dalteparin 5000IU are injected 6 hours after surgery and the concomitant 33 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dalteparin 5000 IU s.c.</intervention_name>
    <description>All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.</description>
    <arm_group_label>dalteparin 5000IU s.c.</arm_group_label>
    <arm_group_label>saline</arm_group_label>
    <other_name>Fragmin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -patients 50 years or older undergoing cemented total hip arthroplasty for primary&#xD;
        osteoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to Low-Molecular-Weight -Heparin&#xD;
&#xD;
          -  bleeding disorders&#xD;
&#xD;
          -  renal failure&#xD;
&#xD;
          -  hepatic disease&#xD;
&#xD;
          -  active treatment for malignancy&#xD;
&#xD;
          -  history of deep venous thrombosis or pulmonary embolism&#xD;
&#xD;
          -  major operations,trauma,stroke or cardiac infarction the last 3 months before surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olav Reikeras, MD, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Martina Hansen's Hospital</name>
      <address>
        <city>Sandvika</city>
        <state>Gjettum</state>
        <zip>1346</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Borgen PO, Dahl OE, Reikeras O. Blood loss in cemented THA is not reduced with postoperative versus preoperative start of thromboprophylaxis. Clin Orthop Relat Res. 2012 Sep;470(9):2591-8. doi: 10.1007/s11999-012-2320-9. Epub 2012 Apr 3.</citation>
    <PMID>22476844</PMID>
  </results_reference>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>December 7, 2012</last_update_submitted>
  <last_update_submitted_qc>December 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Martina Hansen's Hospital</investigator_affiliation>
    <investigator_full_name>Pål Borgen, MD</investigator_full_name>
    <investigator_title>MD.</investigator_title>
  </responsible_party>
  <keyword>cemented total hip arthroplasty</keyword>
  <keyword>blood loss</keyword>
  <keyword>wound discharge</keyword>
  <keyword>thromboprophylaxis</keyword>
  <keyword>biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dalteparin</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</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/NCT01714297
org study id: REK Sør-øst s-08012d
nct id: NCT01714297
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine if there are differences in clinical events, i.e
      bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight
      Heparin) is initiated before or after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: total blood loss
time frame: during and after surgery
description: measured blood loss during surgery and in wound drains
measure: transfusion requirements
time frame: during and after surgery
description: number of units packed red blood cells
measure: incidence of bleeding events
time frame: during and after surgery
description: excessive bleeding, wound hematoma, wound secretion, other bleeding events
measure: other complications
time frame: during and after surgery
description: all other complications related to surgery
arm group label: dalteparin 5000IU s.c.
arm group type: Active Comparator
description: 5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty
arm group label: saline
arm group type: Placebo Comparator
description: Syringes of Saline with the same volume as in the dalteparin injections are injected the evenings before total hip arthroplasty. Dalteparin 5000IU are injected 6 hours after surgery and the concomitant 33 days
intervention type: Drug
intervention name: dalteparin 5000 IU s.c.
description: All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.
arm group label: dalteparin 5000IU s.c.
arm group label: saline
other name: Fragmin
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Olav Reikeras, MD, Phd
role: Study Chair
affiliation: Oslo University Hospital
facility: 
country: Norway
citation: Borgen PO, Dahl OE, Reikeras O. Blood loss in cemented THA is not reduced with postoperative versus preoperative start of thromboprophylaxis. Clin Orthop Relat Res. 2012 Sep;470(9):2591-8. doi: 10.1007/s11999-012-2320-9. Epub 2012 Apr 3.
PMID: 22476844
responsible party type: Principal Investigator
investigator affiliation: Martina Hansen's Hospital
investigator full name: Pål Borgen, MD
investigator title: MD.
mesh term: Arthritis
mesh term: Dalteparin
mesh term: Tinzaparin
mesh term: Heparin, Low-Molecular-Weight