Cohort of Repeat Donor Experiences (CORE) Study

Conditions

• Health Effects (Ferritin Levels, CRP Levels, iGg Levels, Self-reported Health)

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• Plasmapheresis Procedure — 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.

Study Details

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.

Key Dates

Start date

Apr 6, 2026

Status verified

Apr 2026

Primary completion

Jul 1, 2028

Completion

Apr 30, 2029

Study Design

Enrollment

2,090 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Biomarkers [ Time Frame: Baseline and every 8 weeks up to 24 months ]

Central Contacts

• Holly Sawyer
  706-825-7703
  [email protected]
• Kathy Chapman
  [email protected]

Locations (1)

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