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Cohort of Repeat Donor Experiences (CORE) Study

ConditionHealth Effects (Ferritin Levels, CRP Levels, iGg Levels, Self-reported Health)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-74
SponsorWestat

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial population

All adult plasma donors eligible to donate plasma at identified plasma donor centers (main study centers are still pending)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Plasmapheresis Procedure

    Procedure/Surgery

    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.

Treatment groups

2,090 Participants
are divided into 2 treatment groups
Group A: Pilot1 intervention
Group B: Main1 intervention

Trial outcomes

Primary outcomes

1

Biomarkers

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.

Time frame
Baseline and every 8 weeks up to 24 months
2

Short-Term Effects

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

Secondary outcomes

1

Cumulative Health

To assess the medium- and long-term effects of frequent plasmapheresis on cumulative fatigue, subjective health, and risk of acute illness.

Time frame
Baseline and every 4 weeks up to 24 months
2

Donation Practices

To investigate risk factors associated with lapses and discontinuation of plasmapheresis.

Time frame
Baseline through withdrawal

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Westat

Lead sponsor

Plasma Protein Therapeutics Association

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: