None listed
Conditions
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.
Interventions
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
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.
Sponsors
The University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed