Study of Centrifugal Therapeutic Plasma Exchange and Membrane Therapeutic Plasma Exchange; a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to setup and prime the machine (in minutes)
研究概览
简要总结
This study aims at comparing centrifugation based therapeutic plasma exchange (cTPE) versus membrane based therapeutic plasma exchange (mTPE) as regards performance, effectiveness and adverse events in patients indicated for TPE.
详细描述
- Study setting: Patients of this study were recruited from the hemodialysis unit of Alexandria Main University Hospital.
- Study design: Randomized prospective crossover study.
- Study population: Twenty patients having clinical indication for TPE.
- They were divided into 2 groups by 1 to 1 randomization Group A: ten patients received the first session of TPE by cTPE and the second session was performed by mTPE 48 hours later.
Group B: ten patients received the first session of TPE by mTPE and the second session was performed by cTPE 48 hours later.
Only the results of 2 sessions for each group were recorded in the study, even if the patients needed further sessions of TPE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged more than 18 years old having indication for plasma exchange (based on American Society for Apheresis (ASFA) therapeutic category 1, 2, 3).
- •Category I: includes disorders for which TPE is accepted as first-line therapy, either as primary stand-alone treatment or in conjunction with other modes of treatment. Examples include Guillain-Barre syndrome, acquired thrombotic thrombocytopenic purpura, and erythrocytapheresis in sickle cell diseases with certain complications (eg, stroke).
- •Category II: includes disorders for which TPE is accepted as second-line therapy, either as a stand-alone treatment or in conjunction with other modes of treatment. Examples include life-threatening hemolytic anemia for cold agglutinin disease or Lambert-Eaton myasthenic syndrome.
- •Category III: includes disorders for which the optimum role of apheresis therapy is not established. Decision making should be individualized. Examples include TPE for hyper-triglyceridemic pancreatitis or extracorporeal photopheresis for nephrogenic systemic fibrosis.
- •Approval to sign a written consent.
排除标准
- •Refusal to participate in the study.
结局指标
主要结局
Time to setup and prime the machine (in minutes)
时间窗: immediately after plasma exchange procedure
Procedure time (in minutes).
时间窗: immediately after plasma exchange procedure
Time to exchange 1 litre of plasma (in minutes).
时间窗: immediately after plasma exchange procedure
Blood flow rate (ml/minutes)
时间窗: immediately after plasma exchange procedure
Plasma removal efficiency (PRE).
时间窗: immediately after plasma exchange procedure
Plasma removal efficiency is an established metric used to analyse the performance of an apheresis device during a TPE procedure. It represents the fraction of plasma that has been removed in a TPE procedure in relation to the plasma that has been processed.
Efficacy in clearance of interleukin 6 and tumor necrosis factor alpha
时间窗: immediately after plasma exchange procedure
serum level of interleukin 6 and tumor necrosis factor apha were assessed before and after each session of therapeutic plasma exchange
Adverse events
时间窗: immediately after plasma exchange procedure
All adverse events occurring during the session were reported including any of the following * Hemolysis. * Urticaria. * Hypotension. * Hypocalcemia. * Clotting of the extracorporeal circuit. * Others.
次要结局
未报告次要终点