Is therapeutic plasma exchange a better treatment than intravenous immunoglobulin in people with severe Guillain-Barre Syndrome (GBS)?
Does therapeutic plasma exchange improve outcomes in severe Guillain-Barre Syndrome (GBS) compared to intravenous immunoglobulin? A protocol for a New Zealand pilot study
Waikato Hospital
50 participants
Jul 5, 2021
Interventional
Conditions
Summary
This is a prospective, rater-blinded, randomised pilot study to compare the outcome of severe GBS patients (Hughes GBS Disability Scale 4 and 5) treated with TPE vs those patients treated with IVIg. We hypothesise that TPE will lead to improved outcomes in comparison to IVIg therapy in patients with severe GBS
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Therapeutic plasma exchange (TPE): is a semi-automated extracorporeal procedure to exchange the plasma with an inert blood replacement such as Albumin. This helps in the progressive dilution of immunoglobulins which are the presumed target in an autoimmune condition. IRIS TRIAL - THERAPEUTIC PLASMA EXCHANGE PROTOCOL Machine: • Centrifugal apheresis machine Procedure: • 5 – 7 procedures in 7 – 10 days, on alternate days • Initial exchange: 1.2 to 1.5 times Total Plasma Volume (TPV), 90-120 minutes per session • Subsequent exchanges: 1.0 TPV • Replacement solution: 4% Albumin only Monitoring: • At initiation: FBC, Coag Screen, U& E’s, Liver Function tests • Daily coagulation screen in the morning before the procedure • Every patient to be put on Vit K 10mg IV, daily prophylactically The decision of whether or not a participant receives 5, 6 or 7 procedures will be the decision of the "treating" neurologist/clinician (i.e.not the "study" neurologist/research team) to ensure that the care of the patient is kept independent from the study objectives.
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ACTRN12621000815864