ClinicalTrials.gg
RecruitingNCT07137429Updated Jul 31, 2026

Platelet Volunteers, Longitudinal and Multi-omic Study

An observational study in Thrombosis, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Background:

Platelets are a type of blood cell that play a critical role in bleeding, forming blood clots, and healing. Researchers want to know more about platelets work in healthy people. They want to look at how platelets clump together, how blood clots, and how genes and proteins work. They also want to study how these processes change over time and how they are affected by factors such diet, exercise, weight, and new health problems.

Objective:

To study how platelets function in healthy people.

Eligibility:

Healthy people aged 18 years and older.

Design:

Researchers will review participants medical history. They will ask about the participant s family history and any drugs they take.

Participants will have a clinic visit once every 6 or 7 months for 10 years. Each visit will be 2 to 3 hours.

At each visit, participants will have several tests and procedures:

A physical exam, including vital signs. Hip and ankle circumference will be measured.

Urine collection.

Blood tests. About 10 tablespoons of blood will be drawn. Participants will be asked to fast for 10 hours and avoid drugs like aspirin or Advil for 7 days before each draw. Some of the blood may be used for gene studies. Some may be used to create stem cells for research. Stem cells are cells that can be used to make other types of cells.

Surveys and questionnaires. Participants will answer questions about habitual activity, diet, smoking, drugs and alcohol, sleep, illness, and other health issues. These surveys may be done online, via email, or by phone.

Read the detailed description

Study Description:

This study will serve to provide tissue samples from healthy volunteers for mechanistic studies of platelet function.

Objectives:

Primary Objective: The goal is to obtain blood samples and corresponding derived information to optimize assays, understand variation in these assays due to different sources of variation, and conduct statistical association studies with appropriate designs including cross-sectional analysis, and longitudinal analyses. Environmental variables may include health reports, anthropometric variables, questions on habits and risk factors and medication during the study.

Endpoints:

Primary Endpoints: Establish and validate technical assays and equipment (e.g. platelet aggregation, hemostasis measurements, methylation, RNA-seq, proteomics and WGS, in vitro iPSC generation and bench compound and cellular imaging screening, etc.)

Establish normal physiologic mechanisms and platelet-related parameters in healthy participant samples and how these vary longitudinally and are influenced by variables (e.g., reproducibility, fluctuation with changing diet, exercise, weight and other risk factors or new disease onset)

02

Conditions studied

  • Thrombosis

Browse trials for

Keywords

  • PLATELET FUNCTION
  • Platelet biology
03

In context

Thrombosis

955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.

This study's planned enrollment of 400 is above the median of 173 across 384 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 71 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy participants, at least 18 years of age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
400 participants (estimated)

Groups and cohorts

  • Healthy

    Healthy participants, at least 18 years of age

06

What researchers measure

Primary outcomes

  1. Establish and validate technical assays and equipment (e.g. platelet aggregation, hemostasis measurements, methylation, RNA-seq, proteomics and WGS, in vitro iPSC.

    To provide a mechanism for collection of tissue samples from healthy volunteers for use in research studies relating to platelet biology.The goal is to obtain blood samples and corresponding derived information to optimize assays, understand variation in these assays due to different sources of variation, and conduct statistical association studies with appropriate designs including cross-sectional analysis, and longitudinal analyses. Environmental variables may include health reports, anthropometric variables, questions on habits and risk factors and medication during the study.

    Time frame: 10 years

  2. Establish normal physiologic mechanisms and platelet-related parameters. How these vary longitudinally and are influenced by variables (e.g., reproducibility, fluctuation with changing diet, exercise, weight and other factors.

    To provide a mechanism for collection of tissue samples from healthy volunteers for use in research studies relating to platelet biology.The goal is to obtain blood samples and corresponding derived information to optimize assays, understand variation in these assays due to different sources of variation, and conduct statistical association studies with appropriate designs including cross-sectional analysis, and longitudinal analyses. Environmental variables may include health reports, anthropometric variables, questions on habits and risk factors and medication during the study.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • NIH Clinical Center Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
    • Jayson Grey · Contactjayson.grey@nih.gov · (240) 401-6378
08

References and documents

Individual participant data

Plan to share: Yes — See DMSP

Supporting information: Study protocol, Informed consent form

Time frame: Data will be made available at the time of associated publication and the duration of availability is expected to be indefinite but will ultimately be determined by the NHLBI.

Access criteria: Clinical and laboratory data will be collected in the electronic data capture system (CTDB) and analyzed using open-source statistical software packages. Some lab-based research data is collected on specialized instruments and custom processing programs are used to summarize/QC. Those scripts will not be shared unless requested.@@@@@@Data sharing for clinical study (PVLMO)@@@Will be via a separate study accession in dbGaP. Summary level data such as GWAS summary statistics or gene expression level means may be deposited in appropriate public repositories such as NCBI GeoDatasets or the NHLBI GRASP GWAS portal.@@@

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07137429
Responsible party
Sponsor
First posted
Aug 22, 2025
Start date
Mar 26, 2026
Primary completion
Sep 15, 2041 (estimated)
Completion
Sep 15, 2041 (estimated)
Last update
Jul 31, 2026

Study contacts

Jayson J Grey, R.N.
Contact
jayson.grey@nih.gov
(240) 401-6378
Andrew D Johnson, Ph.D.
Contact
johnsonad2@mail.nih.gov
(508) 663-4082
Andrew D Johnson, Ph.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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