NCT07543965

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,090

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

March 25, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 6, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

March 25, 2026

Last Update Submit

April 14, 2026

Conditions

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

Keywords

plasmaplasma-derived therapiespharma

Outcome Measures

Primary Outcomes (2)

  • Biomarkers

    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

    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 Outcomes (2)

  • Cumulative Health

    Baseline and every 4 weeks up to 24 months

  • Donation Practices

    Baseline through withdrawal

Study Arms (2)

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

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

Interventions

Plasmapheresis ProcedurePROCEDURE

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.

MainPilot

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ADMA Biocenters

Dallas, Georgia, 30157, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pilot Study: 3, 6mL whole blood specimen collections from each participant over duration of the study Main Study: Up to 14, 6mL whole blood specimen collections from each participant over duration of the study.

Study Officials

  • Sarah Ball, PhD

    Westat

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Sawyer

CONTACT

706-825-7703hollysawyer@westat.com

Kathy Chapman

CONTACT

kathychapman@westat.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 22, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

April 30, 2029

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(1)