Associations Between Frequent Plasmapheresis, Biomarkers, and Health Outcomes: A 2-Year National Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,090
- 试验地点
- 1
- 主要终点
- Biomarkers
研究概览
简要总结
The Plasma Protein Therapeutics Association (PPTA) sponsors the Cohort of Repeat Donor Experiences (CORE) Study. This is a prospective, observational cohort study that will follow Source Plasma donors for up to 2 years during the main study (anticipated to begin in summer 2026) and up to 3 months during the pilot launching in mid-March 2026. This study aims to confirm a lack of negative health effects Source Plasma donors may experience as a result of frequent plasmapheresis. The study will use data obtained through self-report surveys for the duration of the study along with periodic whole blood sample collections to test for CRP, ferritin, and IgG.
详细描述
The study employs a two-phase prospective design: (1) data collected before and 48-72 hours after an initial plasma Data will be collected through electronic surveys, real-time illness reports, biomarker analyses, and extracts of Blood Establishment Computer Software (BECS) records including donor screening and operational collection processing variables, if available. Study staff (Study Coordinators employed by the plasma collection companies and Westat central study staff) will engage with participants directly and Westat systems will be used for data collection. The pilot study is planned to occur prior to the main study, planned for early 2026, which will validate the feasibility of study methods and generate preliminary data toward the study aims. The pilot study will involve recruitment and enrollment of 50-90 participants at 2 donor centers for a three-month follow-up period. Pilot study participants will follow the main protocol study procedures, with the addition of brief feedback questions about their participant experience and the omission of End of Year Surveys, due to the shorter follow-up time.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-74;
- •Meet health and medical history requirements for being a plasma donor per eCFR::21 CFR 630.10 Subpart B -- General donor eligibility requirements;
- •Willing to provide phone number and mailing address; has access to internet-enabled smartphone device;
- •Plans to remain within local area during study duration; has not donated whole blood within past 12 months;
- •Does not have permanent deferral;
- •Has not donated plasma more than once at a non-participating plasma center;
- •Another member of their household is not enrolled.
排除标准
- 未提供
研究组 & 干预措施
Pilot
Activities: 1 enrollment survey, 1 post-donation survey, 3 monthly surveys, 4 feedback surveys (1-2 questions each) 3, 6mL WB collections, and acute illness surveys, if needed.
干预措施: Plasmapheresis Procedure (Procedure)
Main
Activities: 1 enrollment survey, 1 post-donation survey, up to 22 monthly surveys, up to 14, 6mL WB collections 2 annual surveys, and acute illness surveys, if needed.
干预措施: Plasmapheresis Procedure (Procedure)
结局指标
主要结局
Biomarkers
时间窗: Baseline and every 8 weeks up to 24 months
To investigate the direct effects of the frequency, recency, and volume of plasmapheresis on biochemical markers and evaluate their role as mediators in the relationship between plasmapheresis and health outcomes.
Short-Term Effects
时间窗: Baseline and 48 hours following baseline
To evaluate the short-term effects of plasmapheresis such as post-donation symptoms and functional impairments (e.g., fatigue, subjective health), including issues noted during the collection process, and their associations with subsequent donation behavior.
次要结局
- Cumulative Health(Baseline and every 4 weeks up to 24 months)
- Donation Practices(Baseline through withdrawal)