Cohort of Repeat Donor Experiences (CORE) Study (CORE)

April 14, 2026 updated by: Westat

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2090

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pilot
Activities: 1 enrollment survey, 1 post-donation survey, 3 monthly surveys, 4 feedback surveys (1-2 questions each) 3, 6mL WB collections, and acute illness surveys, if needed.
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.
Main
Activities: 1 enrollment survey, 1 post-donation survey, up to 22 monthly surveys, up to 14, 6mL WB collections 2 annual surveys, and acute illness surveys, if needed.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers
Time Frame: Baseline and every 8 weeks up to 24 months
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.
Baseline and every 8 weeks up to 24 months
Short-Term Effects
Time Frame: Baseline and 48 hours following baseline
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.
Baseline and 48 hours following baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Health
Time Frame: Baseline and every 4 weeks up to 24 months
To assess the medium- and long-term effects of frequent plasmapheresis on cumulative fatigue, subjective health, and risk of acute illness.
Baseline and every 4 weeks up to 24 months
Donation Practices
Time Frame: Baseline through withdrawal
To investigate risk factors associated with lapses and discontinuation of plasmapheresis.
Baseline through withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Westat

Collaborators

Plasma Protein Therapeutics Association

Investigators

  • Principal Investigator: Sarah Ball, PhD, Westat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 6, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 96955

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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