RecruitingACTRN12621000815864

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


Sponsor

Waikato Hospital

Enrollment

50 participants

Start Date

Jul 5, 2021

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Guillain-Barré Syndrome (GBS) is a rare but serious condition where the immune system mistakenly attacks the nerves, causing rapid-onset weakness that can sometimes progress to paralysis. The two main treatments are intravenous immunoglobulin (IVIg) — which involves infusing antibodies from blood donors — and therapeutic plasma exchange (TPE), which filters the blood to remove the harmful antibodies. Both are proven to help, but it is not clear which works better for the most severely affected patients. This pilot study is randomly assigning patients with severe GBS to receive either IVIg or TPE to compare their recovery outcomes. This is a smaller study designed to test whether a larger definitive trial is feasible. You may be eligible if you are 18 or older and have been diagnosed with GBS at a severity level of 4 or 5 on the standard disability scale, or meet other criteria for severe or respiratory-threatening disease, and can start treatment within two weeks of weakness onset. People with allergies to blood products, IgA deficiency, or who have a medical condition interfering with outcome assessments are not eligible.

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 immuno

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)

Waikato/Wellington/Auckland, New Zealand

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