FatigueCORENCT07543965
Cohort of Repeat Donor Experiences (CORE) Study
An observational study of Fatigue and Acute Illness, run by Westat at 12 sites in United States.
Trial 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 (launching in October 2026) ) and up to 3 months during the pilot inconducted… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Fatigue, Acute Illness, Self-rated Health
- What is being tested?
- Plasmapheresis Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 2,400 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2026to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult plasma donors eligible to donate plasma at identified plasma donor centers (main study centers are still pending)
Who may be able to join
- 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 company plasma center;
- Another member of their household is not enrolled.
- Is not employed by the participating plasma center.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kathy Chapman contact
12 sites in 1 country
United States12 sites
Takeda BioLife
Ammon, Idaho, 83406
Lukus Kapuska, RN, 515-612-8386, lukus.kapuska@takeda.com
Sarah Ball, PhD
Kedplasma
Bowling Green, Kentucky, 42101
Gary Hairston Jr., RN, (270) 793-0425, g.hairston-jr@kedrion.com
Sarah Ball, PhD
Kedplasma
Cocoa, Florida, 32922
Godfrey Lu, RN, (321) 338-1646, g.lu@kedrion.com
Sarah Bell, PhD
Kedplasma
El Paso, Texas, 79901
Ruben Duran, RN, (915) 206-4717, r.duran@kedrion.com
Sarah Ball, PhD
Grifols Biomat
Humble, Texas, 77338
Laura Harvey, RN, 515-612-8386, lflaniken@grifols.com
Sarah Ball, PhD
Grifols Biomat
Merrillville, Indiana, 46410
Jennifer Chapman, RN, (219) 769-7705, Jennifer.Chapman@grifols.com
Sarah Ball, PhD
LFB Plasma
Pueblo, Colorado, 81008
Brenda Landeros, RN, 719-242-9793, Brenda.Landeros@lfbplasma.com
Sarah Ball, PhD
Takeda BioLife
Salisbury, Maryland, 21804
Lukus Kapuska, RN, 515-612-8386, lukus.kapuska@takeda.com
Sarah Ball, PhD
Takeda BioLife
Tempe, Arizona, 85284
Lukus Kapuska, RN, 515-612-8386, lukus.kapuska@takeda.com
Sarah Ball, PhD
Takeda BioLife
West Des Moines, Iowa, 50266
Lukus Kapuska, RN, 515-612-8386, lukus.kapuska@takeda.com
Sarah Ball, PhD
Takeda BioLife
West Springfield, Massachusetts, 01089
Lukus Kapuska, RN, 515-612-8386, lukus.kapuska@takeda.com
Sarah Ball, PhD
Grifols Biomat
Wichita, Kansas, 67206
Megan Olson, RN, (940) 763-0300, Megan.Olson@grifols.com
Sarah Ball, PhD
About this 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 (launching in October 2026) ) and up to 3 months during the pilot inconducted April - September 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.
Read the detailed description
The study employs a two-phase prospective design: (1) data collected before and 48-72 hours after an initial plasma and (2) data collected for up to 24 months through surveys and specimen collections. 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) will engage with participants directly and Westat systems will be used for data collection. The study is planned to launch in October 2026 on a rolling basis across the United States. The study will involve recruitment and enrollment of 2,400 Source Plasma donors at 12 donor centers for an up to 24 month follow-up period.
- Conditions
- Fatigue, Acute Illness, Self-rated Health, Health Effects (Ferritin Levels, CRP Levels, iGg Levels)
- Being tested
- Plasmapheresis Procedure
- Keywords
- plasma, plasma-derived therapies, pharma
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmapheresis ProcedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Plasmapheresis Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma donation frequency associations with fatigue and self-rated health
To examine whether frequency of plasmapheresis is associated with fatigue and/or self-rated health.
Measured: Baseline and every 4 weeks up to 24 months
Secondary outcomes (4)
Health Impact Outcomes of Fatigue, Self-rated Health, and Acute Illness
To assess the recency and volume of plasmapheresis on fatigue, subjective health, and risk of acute illness.
Measured: Baseline and every 4 weeks up to 24 months
Post Donation Health Outcomes
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.
Measured: Baseline and 48 hours following baseline
Biochemical Markers of IgG, Ferritin, and CRP
To investigate associations with plasmapheresis and changes in IgG, ferritin, and/or CRP.
Measured: Baseline, 4 weeks after enrollment, and every 8 weeks up to 24 months
Donation Lapses
To investigate risk factors associated with lapses and discontinuation of plasmapheresis.
Measured: Baseline through withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startOct 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Plasma Protein Therapeutics Association
- Responsible party
- Sponsor
- Investigators
- Sarah Ball, PhD, Principal investigator, Westat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543965
- Sponsor's protocol ID
- 96955
- Other IDs
- CORE
- Acronym
- CORE
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Repeat Donor Experiences (CORE) Study
- ClinicalTrials.gov ID
- NCT07543965
- Acronym / sponsor ID
- CORE / 96955
- Conditions
- Fatigue, Acute Illness, Self-rated Health, Health Effects (Ferritin Levels, CRP Levels, iGg Levels)
- Keywords
- plasma, plasma-derived therapies, pharma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- WestatUniversity, hospital or other
- Collaborators
- Plasma Protein Therapeutics Association
- Study start
- Oct 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (launching in October 2026) ) and up to 3 months during the pilot inconducted April - September 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 and (2) data collected for up to 24 months through surveys and specimen collections. 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) will engage with participants directly and Westat systems will be used for data collection. The study is planned to launch in October 2026 on a rolling basis across the United States. The study will involve recruitment and enrollment of 2,400 Source Plasma donors at 12 donor centers for an up to 24 month follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot | – | Procedure: Plasmapheresis ProcedureActivities: 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. |
| Main | – | Procedure: Plasmapheresis ProcedureActivities: 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult plasma donors eligible to donate plasma at identified plasma donor centers (main study centers are still pending)
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmapheresis ProcedureBoth 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. | Procedure or surgery | Main, Pilot |
Primary outcome
Plasma donation frequency associations with fatigue and self-rated health
Time frame: Baseline and every 4 weeks up to 24 months
To examine whether frequency of plasmapheresis is associated with fatigue and/or self-rated health.
4 secondary outcomes
Health Impact Outcomes of Fatigue, Self-rated Health, and Acute Illness
Time frame: Baseline and every 4 weeks up to 24 months
Post Donation Health Outcomes
Time frame: Baseline and 48 hours following baseline
Biochemical Markers of IgG, Ferritin, and CRP
Time frame: Baseline, 4 weeks after enrollment, and every 8 weeks up to 24 months
Donation Lapses
Time frame: Baseline through withdrawal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathy Chapman contact
Sarah Ball, PhD principal investigator
Westat
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Acute Illness, run by Westat at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly Sawyer (706-825-7703, hollysawyer@westat.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma donation frequency associations with fatigue and self-rated health (time frame: Baseline and every 4 weeks up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.