Therapeutic Plasma Exchange in Thyrotoxicosis

July 22, 2020 updated by: İlker Murat Arer, Baskent University

Preoperative Therapeutic Plasma Exchange and Surgical Treatment in Thyrotoxicosis Patients: a Single-centre Retrospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

27

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Therapeutic plasma exchange was performed in 27 thyrotoxic patients at the Adult Therapeutic Apheresis Center between January 1999 and February 2019. The patients were previously on treatment and follow-up in the Department of Endocrinology and Metabolism Diseases at our hospital.

Description

Inclusion Criteria:

  • thyrotoxicosis unresponsive to medication
  • adverse reaction to the medications
  • need for rapid treatment in patients that need urgent surgery

Exclusion Criteria:

  • The patients who did not undergo surgery post-therapeutic plasma exchange
  • Preoperative hypocalcemia,
  • hemodynamically unstable patients
  • patients not suitable for central catheter placement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid hormone levels of patients after therapeutic plasma exchange
Time Frame: 1 week before the operation
Concentration of serum thyroid hormone levels before thyroidectomy
1 week before the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1999

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA20/244

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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