Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome.
II. Compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||July 1995|
This is a randomized, multicenter study.
Patients are randomized to receive either human immunoglobulin infusion (IVIg) (arm I) or plasmapheresis (arm II).
Arm I patients receive liquid heat-treated IVIg for 4 days starting on day 1 and then another single infusion of IVIg on day 7, 8, or 9.
Arm II patients receive serial plasmapheresis treatments. The first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days.
Patients are followed at weeks 1, 2, 3, 4, 8, 12, and 24.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004833
|Study Chair:||John T. Sladky||Emory University|