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NOT YET RECRUITING
NCT07543965

Cohort of Repeat Donor Experiences (CORE) Study

Sponsor: Westat

View on ClinicalTrials.gov

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 (launching in October 2026) ) and up to 3 months during the pilot inconducted April - September 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 Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

OBSERVATIONAL

Enrollment

2400

Start Date

2026-10

Completion Date

2029-04-30

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

PROCEDURE

Plasmapheresis 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.

Locations (12)

Takeda BioLife

Tempe, Arizona, United States

LFB Plasma

Pueblo, Colorado, United States

Kedplasma

Cocoa, Florida, United States

Takeda BioLife

Ammon, Idaho, United States

Grifols Biomat

Merrillville, Indiana, United States

Takeda BioLife

West Des Moines, Iowa, United States

Grifols Biomat

Wichita, Kansas, United States

Kedplasma

Bowling Green, Kentucky, United States

Takeda BioLife

Salisbury, Maryland, United States

Takeda BioLife

West Springfield, Massachusetts, United States

Kedplasma

El Paso, Texas, United States

Grifols Biomat

Humble, Texas, United States