<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/NCT02252497</url>
  </required_header>
  <id_info>
    <org_study_id>1308015</org_study_id>
    <secondary_id>2013-000791-15</secondary_id>
    <nct_id>NCT02252497</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid in Total Hip Arthroplasty.</brief_title>
  <acronym>PORTO</acronym>
  <official_title>Tranexamic Acid in Total Hip Arthroplasty: Single Preoperative Administration vs Perioperative Administration. A Randomized Control Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid&#xD;
      (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over&#xD;
      height hours on blood loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid&#xD;
      (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over&#xD;
      eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the&#xD;
      timing of its administration relative to surgery. In total hip arthroplasty, TXA should be&#xD;
      started before surgery. However the optimal duration of TXA administration in hip&#xD;
      arthroplasty is unknown. Numerous studies have shown that a single preoperative&#xD;
      administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of&#xD;
      TXA started before surgery and followed with a continuous infusion or repeated boluses. Our&#xD;
      hypothesis is that a single preoperative administration of TXA is not sufficient to maintain&#xD;
      therapeutic concentrations of TXA in the postoperative period. In addition a&#xD;
      pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA&#xD;
      plasma concentration as a predictor of blood loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Calculated volume of blood losses in the peroperative period.</measure>
    <time_frame>between the beginning of surgery and the fifth day</time_frame>
    <description>It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the patients' percentage that will receive the transfusion of at least one allogenic globular sediment</measure>
    <time_frame>between D1 (day of surgery) and D5 (the fourth postoperative day)</time_frame>
    <description>the patients' percentage that will receive the transfusion of at least one allogenic globular sediment in the peroperative period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of symptomatic thrombotic events and death</measure>
    <time_frame>in 6 weeks</time_frame>
    <description>combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tranexamic acid pharmacokinetic analyses</measure>
    <time_frame>from the beginning of surgery up to 8 hours</time_frame>
    <description>non linear mixt effect model</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Tranexamic acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1g Intra Venous just before surgery&#xD;
Then infusion of 1g of Exacyl over eight hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiologic serum</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1g Intra Venous, just before surgery&#xD;
Then infusion of 1g of physiologic serum over eight hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active comparator : Tranexamic Acid (Exacyl)</intervention_name>
    <description>1g Exacyl Intra Venous, just before surgery&#xD;
Then infusion of 1g of Exacyl over eight hours .</description>
    <arm_group_label>Tranexamic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo comparator : physiologic serum</intervention_name>
    <description>1g Intra Venous just before surgery&#xD;
Then infusion of 1g of physiologic serum over eight hours</description>
    <arm_group_label>Physiologic serum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient requiring hip arthroplasty in first line, except recent hip fracture (less&#xD;
             than 3 months)&#xD;
&#xD;
          -  Consent of the patient or a family member or the support person.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to tranexamic acid.&#xD;
&#xD;
          -  Contraindication to apixaban.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patient receiving a curative anticoagulating treatment in the preoperative period.&#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>Paul ZUFFEREY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>SAINT-ETIENNE cedex 2</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>March 11, 2016</last_update_submitted>
  <last_update_submitted_qc>March 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hip arthroplasty</keyword>
  <keyword>Tranexamic acid</keyword>
  <keyword>randomized control trial</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</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/NCT02252497
org study id: 1308015
secondary id: 2013-000791-15
nct id: NCT02252497
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid
      (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over
      height hours on blood loss.
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid
      (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over
      eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the
      timing of its administration relative to surgery. In total hip arthroplasty, TXA should be
      started before surgery. However the optimal duration of TXA administration in hip
      arthroplasty is unknown. Numerous studies have shown that a single preoperative
      administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of
      TXA started before surgery and followed with a continuous infusion or repeated boluses. Our
      hypothesis is that a single preoperative administration of TXA is not sufficient to maintain
      therapeutic concentrations of TXA in the postoperative period. In addition a
      pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA
      plasma concentration as a predictor of blood loss.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Calculated volume of blood losses in the peroperative period.
time frame: between the beginning of surgery and the fifth day
description: It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day.
measure: the patients' percentage that will receive the transfusion of at least one allogenic globular sediment
time frame: between D1 (day of surgery) and D5 (the fourth postoperative day)
description: the patients' percentage that will receive the transfusion of at least one allogenic globular sediment in the peroperative period.
measure: incidence of symptomatic thrombotic events and death
time frame: in 6 weeks
description: combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death
measure: tranexamic acid pharmacokinetic analyses
time frame: from the beginning of surgery up to 8 hours
description: non linear mixt effect model
arm group label: Tranexamic acid
arm group type: Active Comparator
description: 1g Intra Venous just before surgery
Then infusion of 1g of Exacyl over eight hours.
arm group label: Physiologic serum
arm group type: Placebo Comparator
description: 1g Intra Venous, just before surgery
Then infusion of 1g of physiologic serum over eight hours.
intervention type: Drug
intervention name: Active comparator : Tranexamic Acid (Exacyl)
description: 1g Exacyl Intra Venous, just before surgery
Then infusion of 1g of Exacyl over eight hours .
arm group label: Tranexamic acid
intervention type: Drug
intervention name: Placebo comparator : physiologic serum
description: 1g Intra Venous just before surgery
Then infusion of 1g of physiologic serum over eight hours
arm group label: Physiologic serum
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul ZUFFEREY, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: Tranexamic Acid