Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Level of anti glial fibrillary acid protein antibodies
研究概览
简要总结
The purpose of the study is to detect the presence of autoantibodies and autoantigens in cerebrospinal fluid early (<48 hours) following spinal cord trauma.
The study also aims to define the central or peripheral origin of autoantibodies by looking for their simultaneous presence at the blood level and to evaluate the prognostic value of the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial clinical severity than on the recovery potential.
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
- •Patients with spinal cord injury dating back less than 48 hours
- •Men or women over 18 years of age
- •Patients benefiting from social protection
- •Surgery performed within 48 hours of the trauma
- •Informed and signed consent by the patient or trusted person
排除标准
- •Contra-indication to ensure surgical decompression within the first 48 hours following the trauma
- •Coagulation disorders or any condition that may make the lumbar puncture risky (eg, history of lumbar surgery)
- •Severe cranial trauma associated
- •History of autoimmune pathology
- •Immunosuppressive therapy or long-term corticosteroid therapy
- •Patients unable to comply with protocol requirements
- •Person benefiting from legal protection (guardianship / curator)
- •Person deprived of liberty
- •Patient unable to express consent
- •Pregnant women
结局指标
主要结局
Level of anti glial fibrillary acid protein antibodies
时间窗: The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours.
Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid
次要结局
- Blood level of anti glial fibrillary acid protein antibodies(The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours.)
- Severity of Neurological Impairment(in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year)