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

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 design

Treatments tested in this trial

Plasmapheresis Procedure

Treatment groups

2,090 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Westat

Lead sponsor

Plasma Protein Therapeutics Association

Collaborator

Source ClinicalTrials.gov