Health Effects (Ferritin Levels, CRP Levels, iGg Levels, Self-reported Health)
Conditions
Keywords
plasma, plasma-derived therapies, pharma
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPlasmapheresis 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.
Sponsors
Westat
Plasma Protein Therapeutics Association
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Health | Baseline and every 4 weeks up to 24 months | To assess the medium- and long-term effects of frequent plasmapheresis on cumulative fatigue, subjective health, and risk of acute illness. |
| Donation Practices | Baseline through withdrawal | To investigate risk factors associated with lapses and discontinuation of plasmapheresis. |
Countries
United States
Contacts
CONTACTHolly Sawyer
CONTACTKathy Chapman
PRINCIPAL_INVESTIGATORSarah Ball, PhD
Westat
Outcome results
None listed