<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/NCT04485975</url>
  </required_header>
  <id_info>
    <org_study_id>KA20/244</org_study_id>
    <nct_id>NCT04485975</nct_id>
  </id_info>
  <brief_title>Therapeutic Plasma Exchange in Thyrotoxicosis</brief_title>
  <official_title>Preoperative Therapeutic Plasma Exchange and Surgical Treatment in Thyrotoxicosis Patients: a Single-centre Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baskent University</source>
  <oversight_info>
    <has_dmc>No</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>
      Therapeutic plasma exchange (TPE) is indicated in cases where antithyroid medications cannot&#xD;
      be used due to the side effects or attain no adequate hormonal suppression response at the&#xD;
      highest dosage and in cases of rapid onset of clinical symptoms. This study presents the&#xD;
      treatment results of patients who underwent TPE and subsequently operated for thyrotoxicosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Therapeutic plasma exchange (TPE) is indicated in cases where antithyroid&#xD;
      medications cannot be used due to the side effects or attain no adequate hormonal suppression&#xD;
      response at the highest dosage and in cases of rapid onset of clinical symptoms. This study&#xD;
      presents the treatment results of patients who underwent TPE and subsequently operated for&#xD;
      thyrotoxicosis.&#xD;
&#xD;
      Methods: The files of 27 patients who underwent preoperative TPE for thyrotoxicosis between&#xD;
      January 1999 and February 2019 were retrospectively analyzed. The demographic and clinical&#xD;
      features of the patients were included.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1999</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Thyroid hormone levels of patients after therapeutic plasma exchange</measure>
    <time_frame>1 week before the operation</time_frame>
    <description>Concentration of serum thyroid hormone levels before thyroidectomy</description>
  </primary_outcome>
  <enrollment type="Actual">27</enrollment>
  <condition>Thyrotoxicosis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Therapeutic plasma exchange</intervention_name>
    <description>Therapeutic plasma exchange filtrates plasma and decreases thyroid hormone concentration in the blood</description>
    <other_name>Thyroidectomy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Therapeutic plasma exchange was performed in 27 thyrotoxic patients at the Adult&#xD;
        Therapeutic Apheresis Center between January 1999 and February 2019. The patients were&#xD;
        previously on treatment and follow-up in the Department of Endocrinology and Metabolism&#xD;
        Diseases at our hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  thyrotoxicosis unresponsive to medication&#xD;
&#xD;
          -  adverse reaction to the medications&#xD;
&#xD;
          -  need for rapid treatment in patients that need urgent surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients who did not undergo surgery post-therapeutic plasma exchange&#xD;
&#xD;
          -  Preoperative hypocalcemia,&#xD;
&#xD;
          -  hemodynamically unstable patients&#xD;
&#xD;
          -  patients not suitable for central catheter placement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baskent University</investigator_affiliation>
    <investigator_full_name>İlker Murat Arer</investigator_full_name>
    <investigator_title>Associate Professor Hakan Yabanoglu</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyrotoxicosis</mesh_term>
  </condition_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/NCT04485975
org study id: KA20/244
nct id: NCT04485975
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Therapeutic plasma exchange (TPE) is indicated in cases where antithyroid medications cannot
      be used due to the side effects or attain no adequate hormonal suppression response at the
      highest dosage and in cases of rapid onset of clinical symptoms. This study presents the
      treatment results of patients who underwent TPE and subsequently operated for thyrotoxicosis.
Background: Therapeutic plasma exchange (TPE) is indicated in cases where antithyroid
      medications cannot be used due to the side effects or attain no adequate hormonal suppression
      response at the highest dosage and in cases of rapid onset of clinical symptoms. This study
      presents the treatment results of patients who underwent TPE and subsequently operated for
      thyrotoxicosis.

      Methods: The files of 27 patients who underwent preoperative TPE for thyrotoxicosis between
      January 1999 and February 2019 were retrospectively analyzed. The demographic and clinical
      features of the patients were included.
observational model: Cohort
time perspective: Retrospective
measure: Thyroid hormone levels of patients after therapeutic plasma exchange
time frame: 1 week before the operation
description: Concentration of serum thyroid hormone levels before thyroidectomy
intervention type: Device
intervention name: Therapeutic plasma exchange
description: Therapeutic plasma exchange filtrates plasma and decreases thyroid hormone concentration in the blood
other name: Thyroidectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Baskent University
investigator full name: İlker Murat Arer
investigator title: Associate Professor Hakan Yabanoglu
mesh term: Thyrotoxicosis