<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/NCT03251469</url>
  </required_header>
  <id_info>
    <org_study_id>2</org_study_id>
    <nct_id>NCT03251469</nct_id>
  </id_info>
  <brief_title>Single Dose of Tranexamic Acid and Blood Loss, in Elderly Patients With Hip Fracture</brief_title>
  <official_title>Single Dose of Tranexamic Acid at the Time of Surgery and Blood Loss, in Elderly Patients Undergoing Hip Fracture Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National and Kapodistrian University of Athens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the hypothesis that single dose of tranexamic acid&#xD;
      (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip&#xD;
      fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing&#xD;
      and cemented hemiarthroplasty respectively. After application of inclusion and exclusion&#xD;
      criteria, patients will be randomized in two groups. Group 1 will include patients that&#xD;
      receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that&#xD;
      receive normal saline (control group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of transfusions of allogeneic RBC from surgery up to day 4</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>total blood loss from surgery to day</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of vascular events</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of deaths</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <condition>Hip Fractures</condition>
  <condition>Complication, Postoperative</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intravenous tranexamic acid, 15mg/kg, preoperatively, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous normal saline, 100mg, preoperatively, single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid 15mg/kg , iv, Single Dose</intervention_name>
    <description>Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline, 100mg, iv, Singe dose</intervention_name>
    <description>Normal Saline, 100mg, administered intravenously, preoperatively in single dose</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive elderly patients (age &gt;75 yo) undergoing hip fracture surgery for a stable&#xD;
             or unstable intertrochanteric hip fracture with the insertion of a short&#xD;
             intramedullary nail (IMN) as well as patients treated surgically with cemented&#xD;
             hemiarthroplasty for acute femoral neck (subcapital) hip fracture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication for tranexamic acid&#xD;
&#xD;
          -  Multiple fractures&#xD;
&#xD;
          -  Requirement for anticoagulant therapy that could not be stopped.&#xD;
&#xD;
          -  Ongoing thromboembolic event&#xD;
&#xD;
          -  reduced kidney function&#xD;
&#xD;
          -  malignancy,&#xD;
&#xD;
          -  pathological fracture&#xD;
&#xD;
          -  previous operation on the affected hip&#xD;
&#xD;
          -  Active coronary artery disease (event in the past 12 months).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vasileios S Nikolaou, MD</last_name>
    <phone>+306932543400</phone>
    <email>vassilios.nikolaou@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>2nd Department of Orthopaedics</name>
      <address>
        <city>Athens</city>
        <state>Attika</state>
        <zip>14233</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vasileios Nikolaou, MD</last_name>
      <phone>+306932543400</phone>
      <email>vassilios.nikolaou@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National and Kapodistrian University of Athens</investigator_affiliation>
    <investigator_full_name>Vasileios S. Nikolaou</investigator_full_name>
    <investigator_title>Assistant Professor of Orthopaedics</investigator_title>
  </responsible_party>
  <keyword>tranexamic acid</keyword>
  <keyword>blood tranfusion</keyword>
  <keyword>hip fractures</keyword>
  <keyword>elderly</keyword>
  <keyword>blood loss</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>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03251469
org study id: 2
nct id: NCT03251469
lead sponsor: 
has dmc: No
The aim of this study is to investigate the hypothesis that single dose of tranexamic acid
      (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip
      fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing
      and cemented hemiarthroplasty respectively. After application of inclusion and exclusion
      criteria, patients will be randomized in two groups. Group 1 will include patients that
      receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that
      receive normal saline (control group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: number of transfusions of allogeneic RBC from surgery up to day 4
time frame: 5 days
measure: total blood loss from surgery to day
time frame: 5 days
measure: incidence of vascular events
time frame: 3 months
measure: Incidence of deaths
time frame: 3 months
arm group label: Group 1
arm group type: Active Comparator
description: intravenous tranexamic acid, 15mg/kg, preoperatively, single dose
arm group label: Group 2
arm group type: Placebo Comparator
description: Intravenous normal saline, 100mg, preoperatively, single dose
intervention type: Drug
intervention name: Tranexamic Acid 15mg/kg , iv, Single Dose
description: Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose
arm group label: Group 1
intervention type: Drug
intervention name: Normal Saline, 100mg, iv, Singe dose
description: Normal Saline, 100mg, administered intravenously, preoperatively in single dose
arm group label: Group 2
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Vasileios S Nikolaou, MD
phone: +306932543400
email: vassilios.nikolaou@gmail.com
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: National and Kapodistrian University of Athens
investigator full name: Vasileios S. Nikolaou
investigator title: Assistant Professor of Orthopaedics
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Postoperative Complications
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Tranexamic Acid
sharing ipd: No