Sickle Cell Anemia Clinical Trial
OBJECTIVES: I. Assess the efficacy of poloxamer 188 in reducing the duration of painful
vaso-occlusive crisis in patients with sickle cell disease.
II. Assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic
use, and length of hospitalization of these patients.
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients are stratified according to hydroxyurea use.
Patients are randomized to treatment poloxamer 188 or placebo. Treatment begins within 12
hours of presentation with crisis. Patients receive poloxamer 188 or placebo by continuous
infusion for 48 hours. Pain is assessed before, during, and after treatment.
Patients are followed on days 7-14 and 28-35.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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