An observational study in Fatigue, Acute Illness and Self-rated Health, sponsored by Westat. Not yet recruiting at 12 sites in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Westat · Observational
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 (launching in October 2026) ) and up to 3 months during the pilot inconducted April - September 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.
The study employs a two-phase prospective design: (1) data collected before and 48-72 hours after an initial plasma and (2) data collected for up to 24 months through surveys and specimen collections. 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) will engage with participants directly and Westat systems will be used for data collection. The study is planned to launch in October 2026 on a rolling basis across the United States. The study will involve recruitment and enrollment of 2,400 Source Plasma donors at 12 donor centers for an up to 24 month follow-up period.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 99 across 406 observational studies indexed under Fatigue.
Browse Fatigue studies →Westat is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 19, 2026. See what changed
All adult plasma donors eligible to donate plasma at identified plasma donor centers (main study centers are still pending)
Inclusion Criteria:
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.
Procedure: Plasmapheresis Procedure
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.
Procedure: Plasmapheresis Procedure
Both pilot and main cohort will undergo plasmapheresis (plasma donation) as part of their initial visit for the study. Some participants will donate plasma throughout the duration of either cohort (3 months in pilot or up to 2 years in the main study.
Plasma donation frequency associations with fatigue and self-rated health
To examine whether frequency of plasmapheresis is associated with fatigue and/or self-rated health.
Time frame: Baseline and every 4 weeks up to 24 months
Health Impact Outcomes of Fatigue, Self-rated Health, and Acute Illness
To assess the recency and volume of plasmapheresis on fatigue, subjective health, and risk of acute illness.
Time frame: Baseline and every 4 weeks up to 24 months
Post Donation Health Outcomes
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.
Time frame: Baseline and 48 hours following baseline
Biochemical Markers of IgG, Ferritin, and CRP
To investigate associations with plasmapheresis and changes in IgG, ferritin, and/or CRP.
Time frame: Baseline, 4 weeks after enrollment, and every 8 weeks up to 24 months
Donation Lapses
To investigate risk factors associated with lapses and discontinuation of plasmapheresis.
Time frame: Baseline through withdrawal
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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