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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Westat

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Plasma Protein Therapeutics Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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