Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
研究概览
简要总结
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008)
- •age 18 years or above
排除标准
- •Clinical or laboratory (C-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection
- •Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment
- •Other contraindications against immunoadsorption or plasma exchange
研究组 & 干预措施
Plasma Exchange
干预措施: Plasma Exchange (Device)
Immunoadsorption
干预措施: Immunoadsorption (Device)
结局指标
主要结局
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
时间窗: 2 weeks
Standard clinical score for inflammatory neuropathies.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score
时间窗: 2 weeks
Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted
Oxford Muscle Strength Score (Medical Research Council, MRC)
时间窗: 2 weeks
Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).
Vibration Score
时间窗: 2 weeks
Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).
次要结局
- Immunoglobulin A in serum(1, 2, 3, and 5 weeks)
- Immunoglobulin M in serum(1, 2, 3, and 5 weeks)
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score(1, 3, and 5 weeks)
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability score(1, 3, and 5 weeks)
- Vibration Score(1, 3, and 5 weeks)
- Hughes Score(1, 2, 3, and 5 weeks)
- Nerve Conduction Velocity(2 and 5 weeks)
- Immunoglobulin A in cerebrospinal fluid (CSF)(2 weeks)
- Interleukin-1(1, 2, 3, and 5 weeks)
- Interleukin-6(1, 2, 3, and 5 weeks)
- Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)(2 weeks)
- Pain(1, 2, 3, and 5 weeks)
- Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)(1, 2, 3, and 5 weeks)
- Immunoglobulin G in serum(1, 2, 3, and 5 weeks)
- Anti-GQ1b(1, 2, 3, and 5 weeks)
- Anti-GM1 antibodies(1, 2, 3, and 5 weeks)
- Oxford Muscle Strength Score (Medical Research Council, MRC)(1, 3, and 5 weeks)
- N20(2 and 5 weeks)
- Immunoglobulin G in cerebrospinal fluid (CSF)(2 weeks)
- Immunoglobulin M in cerebrospinal fluid (CSF)(2 weeks)
- Neurofilament light chain (NfL) serum(1, 2, 3, and 5 weeks)
- Safety and Tolerability(1, 2, 3, and 5 weeks)
- Therapeutic Response(1, 2, 3, and 5 weeks)
- P40(2 and 5 weeks)
研究者
Albert Christian Ludolph, Prof.
Prof. Dr.
University of Ulm