Longitudinal multi-omic platelet volunteer program
Platelet Volunteers, Longitudinal and Multi-omic Study
This program will collect regular blood samples and health data from healthy adults to test how platelets, genes, and proteins change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT07137429 on ClinicalTrials.gov |
What this trial studies
This longitudinal observational program enrolls healthy adults and collects blood, urine, physical exams, and questionnaire data every 6–7 months for up to 10 years. Samples will be used for platelet functional assays (platelet aggregation, hemostasis measurements) and for multi-omic profiling including DNA methylation, RNA-seq, proteomics, whole genome sequencing, plus in vitro iPSC work and imaging. Participants are asked to fast before visits and avoid aspirin/NSAIDs for seven days prior to blood draws to standardize results. The study aims to characterize normal variability in platelet-related measures and their association with lifestyle, anthropometrics, medications, and new health events.
Who should consider this trial
Good fit: Healthy adults age 18 or older who can fast for blood draws, refrain from aspirin/NSAIDs when required, and commit to clinic visits every 6–7 months for up to 10 years.
Not a fit: People with active cancer, known autoimmune disease, major cardiovascular disease, active significant bleeding history, current pregnancy or lactation, or those on regular antiplatelet medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could define normal platelet biology and variability, enabling better diagnostics and more targeted treatments for clotting and bleeding problems.
How similar studies have performed: Cross-sectional platelet and biobank studies have provided useful baseline data, but long-term multi-omic longitudinal profiling of healthy platelet function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Stated willingness to comply with all study procedures, including fasting at least 10 hours before each blood draw * Stated willingness to refrain from aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) for 7 days prior to any visits * Age \>= 18 years * In good general health as evidenced by self-reported medical history EXCLUSION CRITERIA: An individual who, by self-report, meets the following criteria will be excluded from participation in this study: * Current pregnancy or lactation * Active malignancies known, active known auto-immune disease, known major CVD (e.g., heart attack, stroke, venous thromboembolism, heart failure), severe bleeding history, on regular P2Y12 inhibitors or other antiplatelet treatments for a clinical reason, uncontrolled hypertension or diabetes
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Andrew D Johnson, Ph.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Jayson J Grey, R.N.
- Email: jayson.grey@nih.gov
- Phone: (240) 401-6378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.