NCT04485975

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
20.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

20.1 years

First QC Date

June 30, 2020

Last Update Submit

July 22, 2020

Conditions

Thyrotoxicosis

Outcome Measures

Primary Outcomes (1)

  • Thyroid hormone levels of patients after therapeutic plasma exchange

    Concentration of serum thyroid hormone levels before thyroidectomy

    1 week before the operation

Interventions

Therapeutic plasma exchangeDEVICE

Therapeutic plasma exchange filtrates plasma and decreases thyroid hormone concentration in the blood

Also known as: Thyroidectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thyrotoxicosis

Interventions

Plasma ExchangeThyroidectomy

Condition Hierarchy (Ancestors)

HyperthyroidismThyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, OperativeEndocrine Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Hakan Yabanoglu

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 24, 2020

Study Start

January 1, 1999

Primary Completion

February 1, 2019

Study Completion

April 1, 2020

Last Updated

July 24, 2020

Record last verified: 2020-07