Evaluation of Therapeutic Plasma Exchange for Immune-Mediated Neurological Diseases in a Sample of Egyptian Patients: An Experience at Al-Azhar University Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
The goal of this observational study is to Evaluation of Therapeutic Plasma Exchange for Immune-Mediated Neurological Diseases in a Sample of Egyptian Patients: An Experience at Al-Azhar University Hospitals, including evaluating clinical response rates and functional improvement.
详细描述
Therapeutic plasma exchange (TPE) is recommended as Class I therapies by the American Society for Apheresis (ASFA) guidelines and are widely used as first-line therapies for the treatment of acute neuroimmune diseases , TPE is generally well tolerated, with minor complications occurring in about 20-30% of patients ,(ASFA) publishes regular guidelines on the indications for TPE. Studies performed over the last three decades showed that myasthenia gravis (MG), Guillain-Barre syndromé (GBS) and chronic inflammatory demyelinating polyneuropathy (CIDP) were the most frequently cited indications for TPE followed by multiple sclerosis (MS) , The aims of this research to evaluate therapeutic plasma exchange for immune-mediated neurological diseases in a sample of Egyptian patients, including evaluating clinical response rates and functional improvement
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. All neurological patients irrespective of age who will undergo TPE. 2.All new and relapse cases that meet the ASFA guidelines and where TPE is the first and/or second line of therapy
排除标准
- •1. Individuals with contraindications to therapeutic plasma exchange, such as hemodynamic unstable, hypocalcaemia, allergy to fresh frozen plasma or albumin.
- •2.Patients who will undergo fewer than five cycles of TPE and not complete the procedure.
- •3.Patients with non-neurological disorders.
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: will be conducted on each patient on two occasions: prior to and one month subsequent to the completion of plasmapheresis.
The mRS will be rated as follows: 0, no symptoms; 1, no substantial disability; 2, slight disability; 3, moderate disability; 4, moderately severe disability; 5, severe disability; and 6, deceased.
次要结局
未报告次要终点
研究者
Wajdi Hamid Miftah Eisay
resident
Al-Azhar University