ThyrotoxicosisNCT04485975
Therapeutic Plasma Exchange in Thyrotoxicosis
An observational study of Thyrotoxicosis, run by Baskent University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyrotoxicosis
- What is being tested?
- Therapeutic plasma exchange
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- thyrotoxicosis unresponsive to medication
- adverse reaction to the medications
- need for rapid treatment in patients that need urgent surgery
Who cannot join
- The patients who did not undergo surgery post-therapeutic plasma exchange
- Preoperative hypocalcemia,
- hemodynamically unstable patients
- patients not suitable for central catheter placement
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyrotoxicosis
- Being tested
- Therapeutic plasma exchange
- Medical subject headings
- Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic plasma exchangeDevice
Also called Thyroidectomy
Therapeutic plasma exchange filtrates plasma and decreases thyroid hormone concentration in the blood
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid hormone levels of patients after therapeutic plasma exchange
Concentration of serum thyroid hormone levels before thyroidectomy
Measured: 1 week before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jan 1999
- Primary completion1 Feb 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyrotoxicosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker Murat Arer, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485975
- Sponsor's protocol ID
- KA20/244
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Therapeutic Plasma Exchange and Surgical Treatment in Thyrotoxicosis Patients: a Single-centre Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04485975
- Acronym / sponsor ID
- KA20/244
- Conditions
- Thyrotoxicosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- thyrotoxicosis unresponsive to medication
- adverse reaction to the medications
- need for rapid treatment in patients that need urgent surgery
Key exclusion criteria (4 listed)
- The patients who did not undergo surgery post-therapeutic plasma exchange
- Preoperative hypocalcemia,
- hemodynamically unstable patients
- patients not suitable for central catheter placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic plasma exchangeAlso: ThyroidectomyTherapeutic plasma exchange filtrates plasma and decreases thyroid hormone concentration in the blood | Device | – |
Primary outcome
Thyroid hormone levels of patients after therapeutic plasma exchange
Time frame: 1 week before the operation
Concentration of serum thyroid hormone levels before thyroidectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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Thyrotoxicosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyrotoxicosis, run by Baskent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid hormone levels of patients after therapeutic plasma exchange (time frame: 1 week before the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.