Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Acute Disseminated Encephalomyelitis
- 发起方
- National Institute of Neurological Disorders and Stroke (NINDS)
- 入组人数
- 22
- 最后更新
- 20年前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
未指定