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Not yet recruiting NCT07543965

Cohort of Repeat Donor Experiences (CORE) Study

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasmapheresis Procedure.
Who it may be relevant to
Registry conditions: Health Effects (Ferritin Levels, CRP Levels, iGg Levels, Self-reported Health). Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Associations Between Frequent Plasmapheresis, Biomarkers, and Health Outcomes: A 2-Year National Prospective Cohort Study

Overview

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.

Detailed description

The study employs a two-phase prospective design: (1) data collected before and 48-72 hours after an initial plasma Data will be collected through electronic surveys, real-time illness reports, biomarker analyses, and extracts of Blood Establishment Computer Software (BECS) records including donor screening and operational collection processing variables, if available. Study staff (Study Coordinators employed by the plasma collection companies and Westat central study staff) will engage with participants directly and Westat systems will be used for data collection. The pilot study is planned to occur prior to the main study, planned for early 2026, which will validate the feasibility of study methods and generate preliminary data toward the study aims. The pilot study will involve recruitment and enrollment of 50-90 participants at 2 donor centers for a three-month follow-up period. Pilot study participants will follow the main protocol study procedures, with the addition of brief feedback questions about their participant experience and the omission of End of Year Surveys, due to the shorter follow-up time.

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.

Primary outcome measures

  • Biomarkers [Time frame: Baseline and every 8 weeks up to 24 months]
  • Short-Term Effects [Time frame: Baseline and 48 hours following baseline]
Secondary outcome measures (2)
  • Cumulative Health [Time frame: Baseline and every 4 weeks up to 24 months]
  • Donation Practices [Time frame: Baseline through withdrawal]

Eligibility criteria

Inclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • ADMA Biocenters — Dallas

Identifiers

NCT: NCT07543965 · 96955

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗