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|
|Estimated Study Completion Date:||November 2002|
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.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004833
|Study Chair:||John T. Sladky||Emory University|