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Cohort of Repeat Donor Experiences (CORE) Study

NCT07543965 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2090

Last updated 2026-04-22

No results posted yet for this study

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 (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.

Conditions

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

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.

Sponsors & Collaborators

  • Plasma Protein Therapeutics Association

    collaborator UNKNOWN

  • Westat

    lead OTHER

Principal Investigators

  • Sarah Ball, PhD · Westat

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-06
Primary Completion
2028-07-01
Completion
2029-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543965 on ClinicalTrials.gov