<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/NCT02989155</url>
  </required_header>
  <id_info>
    <org_study_id>2015H0427</org_study_id>
    <nct_id>NCT02989155</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty</brief_title>
  <official_title>Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the need for a blood transfusion during surgery and&#xD;
      to evaluate the levels of certain proteins in the blood when given tranexamic acid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A review of the medical record between January 01 2013 to July 1st 2015 will be used to&#xD;
      determine if the hypothesis that patients receiving tranexamic acid will have a lower need&#xD;
      for blood transfusion and there are changes in the levels of the proteins essential for&#xD;
      healthy oxygen transport throughout the body is correct. Tranexamic acid is a medication&#xD;
      which may help wounds to stop bleeding more quickly. Participants are not expected to receive&#xD;
      any direct benefits from participating in this study. Only a small risk of private patient&#xD;
      medical information being exposed is anticipated. The results of this study will help&#xD;
      surgeons and the medical community to better understand the uses of this type of drug and its&#xD;
      possible role in benefiting hip replacement patients during and following surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>hemoglobin, hematocrit, and red blood cell transfusion rates</measure>
    <time_frame>Peri-operative care</time_frame>
    <description>Whether intraoperative dose of 2gr tranexamic acid (TXA) in patients having primary or revision THA would decrease the perioperative and post-operative reduction in hemoglobin, hematocrit, and red blood cell transfusion rates compared with those of a similar group of patients who did not receive TXA (control group).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinically-significant venous thromboembolism (VTE) and all-cause mortality</measure>
    <time_frame>within 30 days of surgery</time_frame>
    <description>frequency of clinically-significant venous thromboembolism (VTE) and all-cause mortality within 30 days of surgery</description>
  </secondary_outcome>
  <enrollment type="Actual">576</enrollment>
  <condition>Tranexamic Acid Use</condition>
  <condition>Blood Loss</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Four surgeons providing total hip replacement services within the date range for data&#xD;
        collection have formally agreed to include their patients in the study population,&#xD;
        therefore identification of patients will occur through screening the surgery log of each&#xD;
        surgeon performing these surgeries within the defined date range.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients 18 years of age and older&#xD;
&#xD;
          -  Surgical patients who underwent primary total hip arthroplasty (THA)&#xD;
&#xD;
          -  Surgical patients who underwent revision THA&#xD;
&#xD;
          -  Preoperative hemoglobin values (N) 11 g/dl&#xD;
&#xD;
          -  Normal international normalized ratio (INR), prothrombin time (PT), partial&#xD;
             thromboplastin time (PTT) values&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Allergy to tranexamic acid&#xD;
&#xD;
          -  Bilateral THA&#xD;
&#xD;
          -  History of ischemic heart disease&#xD;
&#xD;
          -  Severe chronic heart failure&#xD;
&#xD;
          -  Hepatic dysfunction&#xD;
&#xD;
          -  Chronic renal failure&#xD;
&#xD;
          -  On hemodialysis&#xD;
&#xD;
          -  Cerebral infarction&#xD;
&#xD;
          -  History of seizure&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Anticoagulant or aspirin-like medication and long acting NSAID medication&#xD;
&#xD;
          -  Short acting NSAID's were discontinued at least 24 hrs before surgery&#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>Nicoleta Stoicea, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ohio State University Wexner Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Nicoleta Stoicea</investigator_full_name>
    <investigator_title>Research Scientist/ Adj. Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT02989155
org study id: 2015H0427
nct id: NCT02989155
lead sponsor: 
has dmc: No
The purpose of this study is to determine the need for a blood transfusion during surgery and
      to evaluate the levels of certain proteins in the blood when given tranexamic acid.
A review of the medical record between January 01 2013 to July 1st 2015 will be used to
      determine if the hypothesis that patients receiving tranexamic acid will have a lower need
      for blood transfusion and there are changes in the levels of the proteins essential for
      healthy oxygen transport throughout the body is correct. Tranexamic acid is a medication
      which may help wounds to stop bleeding more quickly. Participants are not expected to receive
      any direct benefits from participating in this study. Only a small risk of private patient
      medical information being exposed is anticipated. The results of this study will help
      surgeons and the medical community to better understand the uses of this type of drug and its
      possible role in benefiting hip replacement patients during and following surgery.
observational model: Other
time perspective: Retrospective
measure: hemoglobin, hematocrit, and red blood cell transfusion rates
time frame: Peri-operative care
description: Whether intraoperative dose of 2gr tranexamic acid (TXA) in patients having primary or revision THA would decrease the perioperative and post-operative reduction in hemoglobin, hematocrit, and red blood cell transfusion rates compared with those of a similar group of patients who did not receive TXA (control group).
measure: clinically-significant venous thromboembolism (VTE) and all-cause mortality
time frame: within 30 days of surgery
description: frequency of clinically-significant venous thromboembolism (VTE) and all-cause mortality within 30 days of surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicoleta Stoicea, MD, PhD
role: Principal Investigator
affiliation: The Ohio State University Wexner Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Nicoleta Stoicea
investigator title: Research Scientist/ Adj. Assistant Professor
mesh term: Hemorrhage
sharing ipd: No