Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 170
研究概览
简要总结
OBJECTIVES:
I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome.
II. Compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.
详细描述
PROTOCOL OUTLINE:
This is a randomized, multicenter study.
Patients are randomized to receive either human immunoglobulin infusion (IVIg) (arm I) or plasmapheresis (arm II).
Arm I patients receive liquid heat-treated IVIg for 4 days starting on day 1 and then another single infusion of IVIg on day 7, 8, or 9.
Arm II patients receive serial plasmapheresis treatments. The first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure sensory neuropathy; No prior history of GBS
- •Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable to walk 5 meters without assistance); Must not have improvement of one or more disability grades prior to randomization in this study
- •No paresthesias, numbness, or weakness that began more than 14 days before randomization in this study
- •No CNS involvement
- •-Prior/Concurrent Therapy--
- •Biologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg)
- •Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma)
- •Radiotherapy: Not specified
- •Surgery: Not specified
- •Other: No concurrent mechanical ventilation
- •-Patient Characteristics--
- •Age: Under 18 but with at least 3 months of independent walking
- •Hematopoietic: Cerebrospinal fluid leukocyte count less than 50/mm3
- •Hepatic: No liver failure
- •Renal: No kidney failure
- •Neurological: No other major neurologic diseases, other neuromuscular disorders, or cerebral palsy
- •Other: HIV negative; No contraindications to plasmapheresis or IVIg; No severe uncontrolled infection; No known IgA hypersensitivity; No other preexisting disease that would interfere with assessment of disability grades; No other causes of acquired weakness (e.g., poliomyelitis, botulism, or other etiologies); No diabetes; Not pregnant
排除标准
- 未提供