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CORE Study: Understanding Health Effects of Plasma Donation

This study, called the Cohort of Repeat Donor Experiences (CORE) Study, is looking at the health of people who frequently donate plasma (a part of your blood). It aims to see if there are any negative health effects from repeated plasma donations. You might be able to join if you are between 18 and 74 years old, meet the health requirements for plasma donors, and plan to stay in your local area during the study. The study will involve giving plasma and providing information through surveys, along with blood tests to check levels of certain markers like ferritin (a protein that stores iron), CRP (a marker of inflammation), and IgG (a type of antibody). The study is currently unclear on its recruitment status, but a pilot study is expected to begin in mid-March 2026, with the main study anticipated for summer 2026.

Study design
This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. It plans to enroll 2090 participants, with a smaller pilot study of 50-90 participants.
What's involved
You will undergo plasmapheresis (plasma donation) at your initial visit. Some participants will continue to donate plasma for 3 months in the pilot study or up to 2 years in the main study.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored through biomarkers measured at the start and every 8 weeks for up to 24 months. Short-term effects will be measured at the start and 48 hours later.

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NCT07543965

Cohort of Repeat Donor Experiences (CORE) Study

Not Yet Recruiting
Not specifiedAges 18–74Observational
Westat
~2,090 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Plasmapheresis Procedure

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biomarkers
Measured over Baseline and every 8 weeks up to 24 months
+1 more outcome measured

Conditions

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

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Healthy Volunteer

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Sarah Ball, PhD · PRINCIPAL_INVESTIGATOR · Westat

Who to contact

Holly Sawyer
[email protected]
706-825-7703
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • BiomarkersBaseline 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 EffectsBaseline 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.