<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/NCT04505748</url>
  </required_header>
  <id_info>
    <org_study_id>80/27-01-2017</org_study_id>
    <nct_id>NCT04505748</nct_id>
  </id_info>
  <brief_title>Is Self-transfusion Safe After Total Knee Arthroplasty in Terms of Nephrotoxicity of Gentamicin From Bone Cement?</brief_title>
  <official_title>Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Alexandroupolis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Democritus University of Thrace</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Alexandroupolis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Considering that the high local concentration of antibiotic from bone cement is delivered&#xD;
      intravenously through the self-transfusion process, systematic toxicity has never been&#xD;
      evaluated. In addition, the effectiveness of self-transfusion with the routine concomitant&#xD;
      use of other modern blood-salvage strategies, like tranexamic acid, should be also assessed.&#xD;
      Therefore we performed a randomized study to assess: 1) the safety of self-transfusion in TKA&#xD;
      by comparing the gentamicin concentrations resulting from the use or not of autologous blood&#xD;
      transfusion. 2) the efficacy of self-transfusion in TKA, with the concomitant administration&#xD;
      of tranexamic acid.&#xD;
&#xD;
      The serum concentration of aminoglycosides has been measured in two groups of 20 patients&#xD;
      each, after TKA, according to the use of self-transfusion. Hemoglobin, renal function and&#xD;
      calculated blood loss were compared at several time points between groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gentamicin serum concentration</measure>
    <time_frame>Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.</time_frame>
    <description>using a quantitative fluorescent polarizing immunoassay (FPIA) in the Biochemical analyzer</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Arthroplasty Complications</condition>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Self-transfusion group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients to whom a self-transfusion device has been used after total knee arthroplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients to whom conventional drains have been used after total knee arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Self-transfusion device</intervention_name>
    <description>The Transfusion filter set for salvaged blood (Summit Medical Ltd, Gloucestershire, UK) has been randomly used in 20 patients postoperatively. Patients, who received autologous blood, transfused with the collected amount of blood, only once, 6h postoperatively</description>
    <arm_group_label>Self-transfusion group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  end-stage of knee osteoarthritis, who scheduled for unilateral primary TKA in our&#xD;
             department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who had been treated with gentamicin within the past 10 days&#xD;
&#xD;
          -  known allergies against the bone cement&#xD;
&#xD;
          -  estimated glomerular filtration rate (eGFR) &lt;30ml/minute&#xD;
&#xD;
          -  previous nephrectomy and history of renal transplant&#xD;
&#xD;
          -  contraindications against tranexamic acid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Athanasios Verceridis, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Orthopedics, School of Medicine, Democritus University of Thrace, Greece</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University General Hospital of Alexandroupolis</name>
      <address>
        <city>Alexandroupolis</city>
        <state>Evros</state>
        <zip>68100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Patrick BN, Rivey MP, Allington DR. Acute renal failure associated with vancomycin- and tobramycin-laden cement in total hip arthroplasty. Ann Pharmacother. 2006 Nov;40(11):2037-42. doi: 10.1345/aph.1H173. Epub 2006 Oct 10.</citation>
    <PMID>17032907</PMID>
  </reference>
  <reference>
    <citation>Parvizi J, Saleh KJ, Ragland PS, Pour AE, Mont MA. Efficacy of antibiotic-impregnated cement in total hip replacement. Acta Orthop. 2008 Jun;79(3):335-41. doi: 10.1080/17453670710015229.</citation>
    <PMID>18622836</PMID>
  </reference>
  <results_reference>
    <citation>de Klaver PA, Hendriks JG, van Onzenoort HA, Schreurs BW, Touw DJ, Derijks LJ. Gentamicin serum concentrations in patients with gentamicin-PMMA beads for infected hip joints: a prospective observational cohort study. Ther Drug Monit. 2012 Feb;34(1):67-71. doi: 10.1097/FTD.0b013e31823d7b89.</citation>
    <PMID>22249345</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Alexandroupolis</investigator_affiliation>
    <investigator_full_name>Panagiotis Touzopoulos</investigator_full_name>
    <investigator_title>Consultant of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <keyword>gentamicin</keyword>
  <keyword>self-transfusion</keyword>
  <keyword>blood loss</keyword>
  <keyword>toxicity</keyword>
  <keyword>total knee arthoplasty</keyword>
  <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/NCT04505748
org study id: 80/27-01-2017
nct id: NCT04505748
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Considering that the high local concentration of antibiotic from bone cement is delivered
      intravenously through the self-transfusion process, systematic toxicity has never been
      evaluated. In addition, the effectiveness of self-transfusion with the routine concomitant
      use of other modern blood-salvage strategies, like tranexamic acid, should be also assessed.
      Therefore we performed a randomized study to assess: 1) the safety of self-transfusion in TKA
      by comparing the gentamicin concentrations resulting from the use or not of autologous blood
      transfusion. 2) the efficacy of self-transfusion in TKA, with the concomitant administration
      of tranexamic acid.

      The serum concentration of aminoglycosides has been measured in two groups of 20 patients
      each, after TKA, according to the use of self-transfusion. Hemoglobin, renal function and
      calculated blood loss were compared at several time points between groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Gentamicin serum concentration
time frame: Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours.
description: using a quantitative fluorescent polarizing immunoassay (FPIA) in the Biochemical analyzer
arm group label: Self-transfusion group
arm group type: Experimental
description: Patients to whom a self-transfusion device has been used after total knee arthroplasty.
arm group label: Control group
arm group type: No Intervention
description: Patients to whom conventional drains have been used after total knee arthroplasty.
intervention type: Device
intervention name: Self-transfusion device
description: The Transfusion filter set for salvaged blood (Summit Medical Ltd, Gloucestershire, UK) has been randomly used in 20 patients postoperatively. Patients, who received autologous blood, transfused with the collected amount of blood, only once, 6h postoperatively
arm group label: Self-transfusion group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Athanasios Verceridis, PhD
role: Study Director
affiliation: Associate Professor of Orthopedics, School of Medicine, Democritus University of Thrace, Greece
facility: 
country: Greece
citation: Patrick BN, Rivey MP, Allington DR. Acute renal failure associated with vancomycin- and tobramycin-laden cement in total hip arthroplasty. Ann Pharmacother. 2006 Nov;40(11):2037-42. doi: 10.1345/aph.1H173. Epub 2006 Oct 10.
PMID: 17032907
citation: Parvizi J, Saleh KJ, Ragland PS, Pour AE, Mont MA. Efficacy of antibiotic-impregnated cement in total hip replacement. Acta Orthop. 2008 Jun;79(3):335-41. doi: 10.1080/17453670710015229.
PMID: 18622836
citation: de Klaver PA, Hendriks JG, van Onzenoort HA, Schreurs BW, Touw DJ, Derijks LJ. Gentamicin serum concentrations in patients with gentamicin-PMMA beads for infected hip joints: a prospective observational cohort study. Ther Drug Monit. 2012 Feb;34(1):67-71. doi: 10.1097/FTD.0b013e31823d7b89.
PMID: 22249345
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Alexandroupolis
investigator full name: Panagiotis Touzopoulos
investigator title: Consultant of Orthopaedic Surgery
sharing ipd: No