PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
disease type; each stratum is randomized separately.
The first group of patients receives a true plasma exchange using continuous-flow
centrifugation with serum albumin and crystalloid replacement every 2 days for a total of 7
The second group receives a sham plasma exchange with no centrifugation every 2 days for a
total of 7 exchanges.
Patients cross to the alternate therapy if there is less than a moderate improvement by day
14. The treatment decision is based on a blinded neurologic assessment.
Concurrent corticosteroids and other immunosuppressants, and high-dose barbiturates are not
Patients are followed at 1 and 6 months after the last exchange.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Brian G. Weinshenker
United States: Federal Government