<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/NCT03825939</url>
  </required_header>
  <id_info>
    <org_study_id>WUH 592498-2</org_study_id>
    <nct_id>NCT03825939</nct_id>
  </id_info>
  <brief_title>Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty</brief_title>
  <official_title>Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Winthrop University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study aims to study the use of tranexamic acid (TXA) in total joint replacement&#xD;
      (arthroplasty) of the hip (THR) and knee (TKR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots&#xD;
      from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries&#xD;
      to help reduce surgical complications such as blood loss and blood transfusions.&#xD;
&#xD;
      In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to&#xD;
      effectively reduce blood loss and transfusion requirements without an increased risk of side&#xD;
      effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to&#xD;
      decrease blood loss is crucial, as other studies have shown that reducing blood loss&#xD;
      decreases morbidity and mortality in patients.&#xD;
&#xD;
      Although, many TXA dosing regimens have been studied - all of which have been useful at&#xD;
      reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and&#xD;
      the most cost-effective method of TXA administration for patients have yet to be determined.&#xD;
      Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA&#xD;
      and the effect of TXA on patient outcomes has yet to be conducted.&#xD;
&#xD;
      Therefore, this research study aims to address those concerns in order to understand how best&#xD;
      to use TXA to reduce surgical complications in patients undergoing total joint replacements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of patient enrollment due to only one surgeon that was enrolling.&#xD;
  </why_stopped>
  <start_date type="Actual">April 21, 2015</start_date>
  <completion_date type="Actual">September 6, 2016</completion_date>
  <primary_completion_date type="Actual">July 26, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Required a Blood Transfusion During Surgery</measure>
    <time_frame>operative period (average of 1 hour)</time_frame>
    <description>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Levels of Hematocrit: Pre-operative to Post-operative</measure>
    <time_frame>Day 3 or 4 post surgery</time_frame>
    <description>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>At Hospital Discharge</time_frame>
    <description>Measured in Days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated Blood Loss During Surgery</measure>
    <time_frame>Operative period (an average of 1 hour)</time_frame>
    <description>Surgeon estimated blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hemoglobin: Pre-operative to Post-operative</measure>
    <time_frame>Day 3 or 4 post surgery</time_frame>
    <description>Measured in grams/deciliter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Distance Post Total Joint Arthroplasty of the Hip</measure>
    <time_frame>4 Days</time_frame>
    <description>Walking distance (feet) will be assessed and documented throughout the hospital stay</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Blood Loss</condition>
  <arm_group>
    <arm_group_label>Intravenous Tranexamic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>- IV 0.9% sterile saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous Tranexamic Acid followed by Intravenous Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Placebo</intervention_name>
    <description>IV 0.9% sterile saline</description>
    <arm_group_label>Intravenous Placebo</arm_group_label>
    <arm_group_label>Intravenous Tranexamic Acid followed by Intravenous Placebo</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Tranexamic Acid</intervention_name>
    <description>1g TXA IVPB (intravenous piggyback)</description>
    <arm_group_label>Intravenous Tranexamic Acid</arm_group_label>
    <arm_group_label>Intravenous Tranexamic Acid followed by Intravenous Placebo</arm_group_label>
    <other_name>Tranexamic Acid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  All patients 18 years and older who are already scheduled for primary total joint&#xD;
             arthroplasty of the hip or knee&#xD;
&#xD;
        Exclusion Criteria for IV TXA administration&#xD;
&#xD;
          -  Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)&#xD;
&#xD;
          -  If patient is on anticoagulant, patient must have documented approval from a&#xD;
             cardiologist that patient can be removed from anticoagulant for total joint&#xD;
             arthroplasty procedure&#xD;
&#xD;
          -  Renal impairment defined as serum Cr &gt; 1.5 or Cr Clearance &lt; 50 mL/min&#xD;
&#xD;
          -  Severe ischemic heart disease&#xD;
&#xD;
          -  Color blindness or problems with color vision&#xD;
&#xD;
        Criteria for Use of Topical TXA&#xD;
&#xD;
          -  Topical TXA can be used in any patient meeting one of the exclusion criteria for IV&#xD;
             TXA administration (Section 5.3b) as there is minimal systemic absorption with topical&#xD;
             TXA&#xD;
&#xD;
        Absolute Exclusion Criteria&#xD;
&#xD;
          -  History of deep vein thrombosis (DVT) or pulmonary embolism (PE)&#xD;
&#xD;
          -  Known congenital thrombophilia&#xD;
&#xD;
          -  History of thromboembolic or vascular disease&#xD;
&#xD;
          -  Disseminated intravascular coagulation (DIC)&#xD;
&#xD;
          -  History of seizures&#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>Jan A Koenig, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winthrop University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Winthrop University Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.</citation>
    <PMID>17403800</PMID>
  </reference>
  <reference>
    <citation>Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.</citation>
    <PMID>9973048</PMID>
  </reference>
  <reference>
    <citation>Pedersen AB, Mehnert F, Overgaard S, Johnsen SP. Allogeneic blood transfusion and prognosis following total hip replacement: a population-based follow up study. BMC Musculoskelet Disord. 2009 Dec 29;10:167. doi: 10.1186/1471-2474-10-167.</citation>
    <PMID>20040083</PMID>
  </reference>
  <reference>
    <citation>Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.</citation>
    <PMID>22611164</PMID>
  </reference>
  <reference>
    <citation>Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984.</citation>
    <PMID>21196541</PMID>
  </reference>
  <reference>
    <citation>Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.</citation>
    <PMID>23815893</PMID>
  </reference>
  <reference>
    <citation>Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006 Mar;13(2):106-10. doi: 10.1016/j.knee.2005.11.001. Epub 2006 Feb 17.</citation>
    <PMID>16487712</PMID>
  </reference>
  <reference>
    <citation>Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9.</citation>
    <PMID>16156456</PMID>
  </reference>
  <reference>
    <citation>Niskanen RO, Korkala OL. Tranexamic acid reduces blood loss in cemented hip arthroplasty: a randomized, double-blind study of 39 patients with osteoarthritis. Acta Orthop. 2005 Dec;76(6):829-32. doi: 10.1080/17453670510045444.</citation>
    <PMID>16470437</PMID>
  </reference>
  <reference>
    <citation>Tanaka N, Sakahashi H, Sato E, Hirose K, Ishima T, Ishii S. Timing of the administration of tranexamic acid for maximum reduction in blood loss in arthroplasty of the knee. J Bone Joint Surg Br. 2001 Jul;83(5):702-5. doi: 10.1302/0301-620x.83b5.11745.</citation>
    <PMID>11476309</PMID>
  </reference>
  <reference>
    <citation>Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. Epub 2007 Dec 7.</citation>
    <PMID>18067499</PMID>
  </reference>
  <reference>
    <citation>Camarasa MA, Olle G, Serra-Prat M, Martin A, Sanchez M, Ricos P, Perez A, Opisso L. Efficacy of aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized clinical trial. Br J Anaesth. 2006 May;96(5):576-82. doi: 10.1093/bja/ael057. Epub 2006 Mar 10.</citation>
    <PMID>16531440</PMID>
  </reference>
  <reference>
    <citation>Chang CH, Chang Y, Chen DW, Ueng SW, Lee MS. Topical tranexamic acid reduces blood loss and transfusion rates associated with primary total hip arthroplasty. Clin Orthop Relat Res. 2014 May;472(5):1552-7. doi: 10.1007/s11999-013-3446-0. Epub 2014 Jan 3.</citation>
    <PMID>24385043</PMID>
  </reference>
  <reference>
    <citation>Martin JG, Cassatt KB, Kincaid-Cinnamon KA, Westendorf DS, Garton AS, Lemke JH. Topical administration of tranexamic acid in primary total hip and total knee arthroplasty. J Arthroplasty. 2014 May;29(5):889-94. doi: 10.1016/j.arth.2013.10.005. Epub 2013 Oct 16.</citation>
    <PMID>24238825</PMID>
  </reference>
  <reference>
    <citation>Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):78-82. doi: 10.1016/j.arth.2013.03.038. Epub 2013 Jul 29.</citation>
    <PMID>23906869</PMID>
  </reference>
  <reference>
    <citation>Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.</citation>
    <PMID>23886406</PMID>
  </reference>
  <reference>
    <citation>Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on transfusion rate in primary total hip arthroplasty. J Arthroplasty. 2014 Feb;29(2):387-9. doi: 10.1016/j.arth.2013.05.026. Epub 2013 Jun 21.</citation>
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    <citation>Gilbody J, Dhotar HS, Perruccio AV, Davey JR. Topical tranexamic acid reduces transfusion rates in total hip and knee arthroplasty. J Arthroplasty. 2014 Apr;29(4):681-4. doi: 10.1016/j.arth.2013.09.005. Epub 2013 Oct 4.</citation>
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    <citation>Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.</citation>
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  </reference>
  <reference>
    <citation>Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.</citation>
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  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 23, 2015</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>June 25, 2021</results_first_submitted>
  <results_first_submitted_qc>August 31, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2021</results_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total hip arthroplasty</keyword>
  <keyword>Total knee arthroplasty</keyword>
  <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>Tranexamic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intravenous Tranexamic Acid</title>
          <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
        </group>
        <group group_id="P2">
          <title>Intravenous Placebo</title>
          <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
        </group>
        <group group_id="P3">
          <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
          <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intravenous Tranexamic Acid</title>
          <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
        </group>
        <group group_id="B2">
          <title>Intravenous Placebo</title>
          <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
        </group>
        <group group_id="B3">
          <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
          <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="14"/>
            <count group_id="B4" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" spread="6"/>
                    <measurement group_id="B2" value="67.2" spread="11.4"/>
                    <measurement group_id="B3" value="65.2" spread="12.3"/>
                    <measurement group_id="B4" value="65.6" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-operative hemoglobin</title>
          <units>grams/decileter (g/dl)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.4" spread="1.5"/>
                    <measurement group_id="B2" value="13.6" spread="1.4"/>
                    <measurement group_id="B3" value="13.8" spread="1.5"/>
                    <measurement group_id="B4" value="13.9" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-operative hematocrit</title>
          <units>percentage of red blood cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.6" spread="4.6"/>
                    <measurement group_id="B2" value="41.2" spread="4.2"/>
                    <measurement group_id="B3" value="41.2" spread="4.3"/>
                    <measurement group_id="B4" value="42.0" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Required a Blood Transfusion During Surgery</title>
        <description>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</description>
        <time_frame>operative period (average of 1 hour)</time_frame>
        <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Tranexamic Acid</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Placebo</title>
            <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
          </group>
          <group group_id="O3">
            <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Required a Blood Transfusion During Surgery</title>
          <description>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</description>
          <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Levels of Hematocrit: Pre-operative to Post-operative</title>
        <description>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</description>
        <time_frame>Day 3 or 4 post surgery</time_frame>
        <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Tranexamic Acid</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Placebo</title>
            <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
          </group>
          <group group_id="O3">
            <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Levels of Hematocrit: Pre-operative to Post-operative</title>
          <description>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</description>
          <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <description>Measured in Days</description>
        <time_frame>At Hospital Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Tranexamic Acid</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Placebo</title>
            <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
          </group>
          <group group_id="O3">
            <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>Measured in Days</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="3" upper_limit="3"/>
                    <measurement group_id="O2" value="3" lower_limit="2.5" upper_limit="3"/>
                    <measurement group_id="O3" value="3" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Blood Loss During Surgery</title>
        <description>Surgeon estimated blood loss</description>
        <time_frame>Operative period (an average of 1 hour)</time_frame>
        <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Tranexamic Acid</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Placebo</title>
            <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
          </group>
          <group group_id="O3">
            <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Blood Loss During Surgery</title>
          <description>Surgeon estimated blood loss</description>
          <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hemoglobin: Pre-operative to Post-operative</title>
        <description>Measured in grams/deciliter</description>
        <time_frame>Day 3 or 4 post surgery</time_frame>
        <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Tranexamic Acid</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Placebo</title>
            <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
          </group>
          <group group_id="O3">
            <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hemoglobin: Pre-operative to Post-operative</title>
          <description>Measured in grams/deciliter</description>
          <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Walking Distance Post Total Joint Arthroplasty of the Hip</title>
        <description>Walking distance (feet) will be assessed and documented throughout the hospital stay</description>
        <time_frame>4 Days</time_frame>
        <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Intravenous Tranexamic Acid</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
          <group group_id="O2">
            <title>Intravenous Placebo</title>
            <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
          </group>
          <group group_id="O3">
            <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
            <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
          </group>
        </group_list>
        <measure>
          <title>Walking Distance Post Total Joint Arthroplasty of the Hip</title>
          <description>Walking distance (feet) will be assessed and documented throughout the hospital stay</description>
          <population>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intravenous Tranexamic Acid</title>
          <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
        </group>
        <group group_id="E2">
          <title>Intravenous Placebo</title>
          <description>- IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline</description>
        </group>
        <group group_id="E3">
          <title>Intravenous Tranexamic Acid Followed by Intravenous Placebo</title>
          <description>1g TXA administered intravenous piggyback at start of surgery OR&#xD;
1g TXA administered intravenous piggyback at start and at time of closure of surgery&#xD;
IV 0.9% sterile saline&#xD;
Intravenous Placebo: IV 0.9% sterile saline&#xD;
Intravenous Tranexamic Acid: 1g TXA IVPB</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jan Koenig</name_or_title>
      <organization>NYU Langone</organization>
      <phone>516-678-2232</phone>
      <email>Jan.Koenig@nyulangone.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03825939
org study id: WUH 592498-2
nct id: NCT03825939
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This research study aims to study the use of tranexamic acid (TXA) in total joint replacement
      (arthroplasty) of the hip (THR) and knee (TKR).
Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots
      from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries
      to help reduce surgical complications such as blood loss and blood transfusions.

      In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to
      effectively reduce blood loss and transfusion requirements without an increased risk of side
      effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to
      decrease blood loss is crucial, as other studies have shown that reducing blood loss
      decreases morbidity and mortality in patients.

      Although, many TXA dosing regimens have been studied - all of which have been useful at
      reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and
      the most cost-effective method of TXA administration for patients have yet to be determined.
      Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA
      and the effect of TXA on patient outcomes has yet to be conducted.

      Therefore, this research study aims to address those concerns in order to understand how best
      to use TXA to reduce surgical complications in patients undergoing total joint replacements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Who Required a Blood Transfusion During Surgery
time frame: operative period (average of 1 hour)
description: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
measure: Change in Levels of Hematocrit: Pre-operative to Post-operative
time frame: Day 3 or 4 post surgery
description: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
measure: Length of Hospital Stay
time frame: At Hospital Discharge
description: Measured in Days
measure: Estimated Blood Loss During Surgery
time frame: Operative period (an average of 1 hour)
description: Surgeon estimated blood loss
measure: Change in Hemoglobin: Pre-operative to Post-operative
time frame: Day 3 or 4 post surgery
description: Measured in grams/deciliter
measure: Walking Distance Post Total Joint Arthroplasty of the Hip
time frame: 4 Days
description: Walking distance (feet) will be assessed and documented throughout the hospital stay
arm group label: Intravenous Tranexamic Acid
arm group type: Experimental
description: 1g TXA administered intravenous piggyback at start of surgery OR
1g TXA administered intravenous piggyback at start and at time of closure of surgery
arm group label: Intravenous Placebo
arm group type: Placebo Comparator
description: - IV 0.9% sterile saline
arm group label: Intravenous Tranexamic Acid followed by Intravenous Placebo
arm group type: Active Comparator
description: 1g TXA administered intravenous piggyback at start of surgery OR
1g TXA administered intravenous piggyback at start and at time of closure of surgery
IV 0.9% sterile saline
intervention type: Drug
intervention name: Intravenous Placebo
description: IV 0.9% sterile saline
arm group label: Intravenous Placebo
arm group label: Intravenous Tranexamic Acid followed by Intravenous Placebo
other name: Saline
intervention type: Drug
intervention name: Intravenous Tranexamic Acid
description: 1g TXA IVPB (intravenous piggyback)
arm group label: Intravenous Tranexamic Acid
arm group label: Intravenous Tranexamic Acid followed by Intravenous Placebo
other name: Tranexamic Acid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan A Koenig, M.D.
role: Principal Investigator
affiliation: Winthrop University Hospital
facility: 
country: United States
citation: Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PMID: 17403800
citation: Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.
PMID: 9973048
citation: Pedersen AB, Mehnert F, Overgaard S, Johnsen SP. Allogeneic blood transfusion and prognosis following total hip replacement: a population-based follow up study. BMC Musculoskelet Disord. 2009 Dec 29;10:167. doi: 10.1186/1471-2474-10-167.
PMID: 20040083
citation: Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
PMID: 22611164
citation: Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984.
PMID: 21196541
citation: Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.
PMID: 23815893
citation: Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006 Mar;13(2):106-10. doi: 10.1016/j.knee.2005.11.001. Epub 2006 Feb 17.
PMID: 16487712
citation: Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9.
PMID: 16156456
citation: Niskanen RO, Korkala OL. Tranexamic acid reduces blood loss in cemented hip arthroplasty: a randomized, double-blind study of 39 patients with osteoarthritis. Acta Orthop. 2005 Dec;76(6):829-32. doi: 10.1080/17453670510045444.
PMID: 16470437
citation: Tanaka N, Sakahashi H, Sato E, Hirose K, Ishima T, Ishii S. Timing of the administration of tranexamic acid for maximum reduction in blood loss in arthroplasty of the knee. J Bone Joint Surg Br. 2001 Jul;83(5):702-5. doi: 10.1302/0301-620x.83b5.11745.
PMID: 11476309
citation: Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. Epub 2007 Dec 7.
PMID: 18067499
citation: Camarasa MA, Olle G, Serra-Prat M, Martin A, Sanchez M, Ricos P, Perez A, Opisso L. Efficacy of aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized clinical trial. Br J Anaesth. 2006 May;96(5):576-82. doi: 10.1093/bja/ael057. Epub 2006 Mar 10.
PMID: 16531440
citation: Chang CH, Chang Y, Chen DW, Ueng SW, Lee MS. Topical tranexamic acid reduces blood loss and transfusion rates associated with primary total hip arthroplasty. Clin Orthop Relat Res. 2014 May;472(5):1552-7. doi: 10.1007/s11999-013-3446-0. Epub 2014 Jan 3.
PMID: 24385043
citation: Martin JG, Cassatt KB, Kincaid-Cinnamon KA, Westendorf DS, Garton AS, Lemke JH. Topical administration of tranexamic acid in primary total hip and total knee arthroplasty. J Arthroplasty. 2014 May;29(5):889-94. doi: 10.1016/j.arth.2013.10.005. Epub 2013 Oct 16.
PMID: 24238825
citation: Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):78-82. doi: 10.1016/j.arth.2013.03.038. Epub 2013 Jul 29.
PMID: 23906869
citation: Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.
PMID: 23886406
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citation: Fu DJ, Chen C, Guo L, Yang L. Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials. Chin J Traumatol. 2013;16(2):67-76.
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citation: Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.
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responsible party type: Sponsor
mesh term: Hemorrhage
mesh term: Tranexamic Acid
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 