Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 497
研究概览
简要总结
OBJECTIVES:
I. Compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone (MePRDL) versus tirilazad for patients with acute spinal cord injury.
II. Compare neurologic recovery following 24- and 48-hour MePRDL infusions.
详细描述
PROTOCOL OUTLINE:
This is a randomized, double-blind study. Patients are stratified by participating institution.
Patients are randomly assigned to 1 of 3 treatment groups within 6 hours of injury. Treatment begins within 2 hours of randomization.
One group receives a 24-hour methylprednisolone (MePRDL) infusion: a loading dose followed in 45 minutes by a 23-hour continuous infusion. A placebo for tirilazad is also administered.
A second group receives the same MePRDL loading dose but the continuous infusion is maintained for 48 hours. A placebo for tirilazad is also administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Acute spinal cord injury; diagnosis confirmed by study physician using National Acute Spinal Cord Injury Study neurologic exam
- •Glasgow Coma Score greater than 9
- •Randomization within 6 hours of injury required; treatment must begin within 8 hours of injury
- •No root involvement only; no cauda equina only
- •-Prior/Concurrent Therapy--
- •Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed
- •-Patient Characteristics--
- •Hematopoietic: No hematologic contraindication to protocol therapy
- •Cardiovascular: No vascular contraindication to protocol therapy
- •Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No patients under indictment or incarcerated; No conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status
排除标准
- 未提供