Acute Disseminated Encephalomyelitis Clinical Trial
OBJECTIVES:
I. Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of
inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.
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
exchanges.
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
allowed.
Patients are followed at 1 and 6 months after the last exchange.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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