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Trial registered on ANZCTR
Registration number
ACTRN12624001411538
Ethics application status
Approved
Date submitted
13/11/2024
Date registered
29/11/2024
Date last updated
29/11/2024
Date data sharing statement initially provided
29/11/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Plasmapheresis for Treatment Refractory Postural Orthostatic Tachycardia Syndrome
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Scientific title
Impact of Plasmapheresis on Autonomic Symptom Burden in those living with treatment refractory Postural Orthostatic Tachycardia Syndrome
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Secondary ID [1]
311989
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None
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Universal Trial Number (UTN)
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Trial acronym
PLEX POTS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postural Orthostatic Tachycardia Syndrome
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Condition category
Condition code
Neurological
330289
330289
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention under investigation is plasmapheresis. This is a procedure in which plasma is separated and removed from blood and will be replaced by albumin. This is undertaken by an apheresis machine in a hospital setting, under the care of specialist health care providers. The procedure is undertaken by intravenous access, either through a central or peripheral catheter. The volume of plasma removed is based on the total blood volume (TBV) of each participant. This differs for every person and is based off Nadler's formula which account for the participant's height, weight and sex and also utilised haemotcrit to calculate TBV. The volume removed is similar to replacement fluid volume after accounting for citrate infusion. Fluid balance at the completion of each session is equal to baseline values. Each session is expected to take 3-4 hours, accounting for establishing vascular access. The frequency of sessions will be as follows: four times over a two week period and then fortnightly over a ten week period. At the end of this period, participants will complete the Composite Autonomic Symptom Score (COMPASS-31) questionnaire, with those demonstrating an improvement of 10 points or greater on this questionnaire compared to their baseline values proceeding to a further four sessions of plasmapheresis occurring once every three weeks. Adherence to the intervention will be assessed by medical record review.
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Intervention code [1]
328450
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Treatment: Other
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Comparator / control treatment
The comparative treatment is intravenous fluids which will be administered by peripheral catheter. One litre of Hartmann's solution will be administered at the same frequency as plasmapheresis sessions, as outlined in the intervention arm description.
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Control group
Active
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Outcomes
Primary outcome [1]
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Autonomic symptom burden
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Assessment method [1]
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COMPASS-31 questionnaire
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Timepoint [1]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention (primary timepoint).
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Secondary outcome [1]
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Gastrointestinal symptom burden
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Assessment method [1]
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Gastroparesis Cardinal Symptom Index Score (total score and sub domains)
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Timepoint [1]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Secondary outcome [2]
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Anxiety score
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Assessment method [2]
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Hospital Anxiety and Depression Scale questionnaire
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Timepoint [2]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Secondary outcome [3]
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Sudomotor function
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Assessment method [3]
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SUDOSCAN testing
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Timepoint [3]
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Baseline and at six months post commencement of the intervention
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Secondary outcome [4]
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Functional capacity and disability
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Assessment method [4]
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World Health Organisation Disability Assessment Schedule (WHO-DAS) questionnaire
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Timepoint [4]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention
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Secondary outcome [5]
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Cognitive function
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Assessment method [5]
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Cambridge Neuropsychological Test Automated Battery
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Timepoint [5]
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Baseline and 6 months post commencement of the intervention
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Secondary outcome [6]
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Depression score
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Assessment method [6]
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Hospital Anxiety and Depression Scale
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Timepoint [6]
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Baseline, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Secondary outcome [7]
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Blood markers for inflammation including high sensitivity CRP, IL-1, IL-6 and IL-17 cytokines
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Assessment method [7]
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Phlebotomy
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Timepoint [7]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Secondary outcome [8]
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Autonomic testing parameters
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Assessment method [8]
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Active Stand Test utilising beat to beat haemodynamic monitoring to determine changes in heart rate and blood pressure.
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Timepoint [8]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Secondary outcome [9]
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Postural Orthostatic Tachycardia Syndrome (POTS) symptom burden
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Assessment method [9]
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Malmo POTS questionnaire
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Timepoint [9]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Secondary outcome [10]
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Fatigue
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Assessment method [10]
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Fatigue Severity Scale questionnaire
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Timepoint [10]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Secondary outcome [11]
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Health related quality of life
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Assessment method [11]
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EQ-5D-5L
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Timepoint [11]
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Secondary outcome [12]
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Blood test markers for autoimmunity including ANA, cardiolipin and Beta 2 Glycoprotein antibodies, ENA panel.
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Assessment method [12]
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Phlebotomy
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Timepoint [12]
434206
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Baseline, 2 weeks post commencement of the intervention, 3 months post commencement of the intervention and 6 months post commencement of the intervention.
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Eligibility
Key inclusion criteria
1. Confirmed POTS diagnosis as per standard criteria with lifestyle adjustments [adequate fluid intake, increased salt intake, use of compression wear if tolerated and exercise physiology attendance] and pharmacological treatments trialled for at least 12 months;
2. Evidence of autoimmunity. This is defined as [A]: ANA titre of greater than 1:360; or [B]: greater than or equal to 1 comorbid autoimmune condition; or [C]: two first degree relatives with autoimmune conditions; or [D]: presence of other autoimmune antibodies;
3. Participants must also demonstrate at least one related symptom from three of the following areas below: [A] Severe gastrointestinal dysfunction including gastroparesis, weight loss and/or Gastroparesis Cardinal Symptom Index Score greater than or equal to 2; [B] Neurocognitive impairment e.g., new onset attention deficit hyperactivity disorder, refractory migraine or headache; [C] Bladder symptoms e.g., overactive, or neurogenic bladder, frequent urinary tract infections, nocturia; [D] Significant fatigue, defined as Fatigue Severity Scale score greater than 36/63; [E] evidence of moderately or severely reduced sudomotor function in at least two peripheral sites OR reduced small nerve fibre density on biopsy.
4. Evidence of functional incapacity e.g., unable to attend work or education
5. Ambulant to a level suitable for management in a hospital outpatient department
6. Greater than or equal to 18 years of age.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Unable to provide informed consent;
2. Unable to attend hospital for plasmapheresis;
3. Unable attend baseline tests and study follow-ups;
4. Current treatment with any Immunosuppressant medications within 1-month prior to randomisation;
5. Pregnant or planning to become pregnant during the expected study duration;
6. Suffers from severe mental health disorders where apheresis may compromise medication management of these conditions.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur within a Research Electronic Data Capture (REDCap) database
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur in a 1:1 fashion with randomly permuted blocks of 4 to 6.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/12/2024
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Actual
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Date of last participant enrolment
Anticipated
1/06/2027
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
28
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
316337
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Charities/Societies/Foundations
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Name [1]
316337
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Dysautonomia International
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Address [1]
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Country [1]
316337
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United States of America
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Primary sponsor type
University
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Name
The University of Adelaide
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Address
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Country
Australia
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Secondary sponsor category [1]
318522
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Hospital
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Name [1]
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Royal Adelaide Hospital
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Address [1]
318522
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Country [1]
318522
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315147
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
315147
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
315147
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Australia
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Date submitted for ethics approval [1]
315147
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12/04/2024
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Approval date [1]
315147
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25/07/2024
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Ethics approval number [1]
315147
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2023/HRE00220
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Ethics committee name [2]
315150
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University of Adelaide Human Research Ethics Committee
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Ethics committee address [2]
315150
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https://www.adelaide.edu.au/research-services/ethics-compliance-integrity/human-research-ethics/human-research-ethics-committee
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Ethics committee country [2]
315150
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Australia
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Date submitted for ethics approval [2]
315150
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20/05/2024
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Approval date [2]
315150
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25/09/2024
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Ethics approval number [2]
315150
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Summary
Brief summary
The primary purpose of this study is to determine if plasmapheresis, a medical intervention undertaken in hospital and used for treatment of some autoimmune conditions, may reduce symptoms in people who are living with Postural Orthostatic Tachycardia Syndrome (POTS), that has not improved with standard lifestyle and pharmacological measures. Plasmapheresis involves separating out plasma from other parts of the blood and replacing this with a different fluid. The hypothesis of this study is that plasmapheresis will be superior to intravenous fluids in reducing autonomic symptom burden.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Dennis Lau
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Address
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South Australian Health and Medical Research Institute, North Terrace, Adelaide, South Australia, 5000, Australia
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Country
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Australia
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Phone
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+61 8 8128 4277
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Fax
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Email
133818
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[email protected]
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Contact person for public queries
Name
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Celine Gallagher
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Address
133819
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South Australian Health and Medical Research Institute, North Terrace, Adelaide, South Australia, 5000, Australia
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Country
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Australia
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Phone
133819
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+61 8 8128 4277
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Fax
133819
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Email
133819
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[email protected]
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Contact person for scientific queries
Name
133820
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Celine Gallagher
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Address
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South Australian Health and Medical Research Institute, North Terrace, Adelaide, South Australia, 5000, Australia
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Country
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Australia
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Phone
133820
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+61 8 8128 4277
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Fax
133820
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Email
133820
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Data will be available to other researchers who propose a proposal that is deemed satisfactory by the Steering Committee of this trial.
Conditions for requesting access:
•
-
What individual participant data might be shared?
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Deidentified data on study outcomes will be available.
What types of analyses could be done with individual participant data?
•
Data will only be made available for the purposes outlined in study proposals or for individual participant data as part of meta analyses.
When can requests for individual participant data be made (start and end dates)?
From:
Data will be available from six months after the publication of the main results for a period of 5 years.
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
•
From the principal investigator who can be contacted at
[email protected]
.
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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