NCT00004833

Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (planned)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: 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.

Detailed description

PROTOCOL OUTLINE: 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

Conditions

• Guillain-Barre Syndrome

Interventions

Type	Name	Description
DRUG	Immune globulin

Timeline

• Start date: 1995-07-01
• Completion: 2002-11-01
• First posted: 2000-02-25
• Last updated: 2015-04-07