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
Inclusion Criteria5
- A diagnosis of GBS by Cornblath and Asbury criteria .
- GBS severity of 4 or 5 by Hughes GBS severity scale OR early treatment outcome (EGOS) score of 5 or greater OR early GBS respiratory insufficiency (EGRIS) score of 5 or greater.
- Able to start assigned treatment within 2 weeks of weakness onset.
- At least 18 years of age at the time of enrollment.
- Able to provide informed consent
Exclusion Criteria6
- Any antecedent illness that would interfere with the ability to perform outcome assessments
- History of an allergy to IVIg
- History of an allergic reaction to Albumin 4%.
- History of IgA deficiency with anti-IgA antibodies
- Known reaction to blood products
- Patient with strong objection to the use of blood products
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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.
Locations(1)
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ACTRN12621000815864