Study of the Side Effects of Plasmapheresis: a Multi-modal Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Blood markers
研究概览
简要总结
Only very few studies have prospectively looked at the effect of repeated intensive plasma donation. In collaboration with the Rode Kruis Vlaanderen, we have recently found that repeated whole blood donation with a 3-month interval in between induced a drop in markers for iron status, which worsened with the number of donations. The repetition effect of the donations, whether whole blood or plasma, can be different from the effects measured after one single donation. It is therefore critical to test and document this repetitive effect to build trustable and valid guidelines concerning repetitive plasma donation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age between 18-50 years
- •BMI between 20-28 kg/m2
- •aptitude to perform maximal physical efforts assessed by the physical activity readiness questionnaire (PAR-Q)
排除标准
- •The specific exclusion criteria of the Rode Kruis Vlaanderen for blood donation will not be systematically applied to the present study to increase the pool of recruitment.
- •In case the subjects do not comply with the criteria of the Rode Kruis Vlaanderen, their plasma donations will be thrown away.
- •In case the subjects comply, their plasma donations will be handled as usually.
- •The criteria will be assessed before each plasma donation by a questionnaire as usually done in the Center of the Rode Kruis.
研究组 & 干预措施
Placebo
Simulated plasma donation, same procedure as for plasmapheresis but without drawing blood.
干预措施: Plasmapheresis (Device)
Low-frequency
Plasma donation 1x/month for 3 months
干预措施: Plasmapheresis (Device)
High-frequency
Plasma donation 3x/month for 3 months
干预措施: Plasmapheresis (Device)
US scheme
Plasma donation 2x/week for 3 months
干预措施: Plasmapheresis (Device)
结局指标
主要结局
Blood markers
时间窗: 3 months
albumin in g/l
Sport performance
时间窗: 3 months
VO2max in mlO2/kg/min determined breath-by-breath on a cycloergometer
次要结局
- Body composition(3 months)
- Blood pressure(3 months)