ThrombosisNCT07137429
Platelet Volunteers, Longitudinal and Multi-omic Study
An observational study of Thrombosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to 15 Sep 2041
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants, at least 18 years of age
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
Jayson Grey, (240) 401-6378, jayson.grey@nih.gov
About this study
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.
Read more
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)
- Conditions
- Thrombosis
- Keywords
- PLATELET FUNCTION, Platelet biology
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy participants, at least 18 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start26 Mar 2026
- Primary completion15 Sep 2041 (estimated)
- Study completion15 Sep 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew D Johnson, Ph.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137429
- Sponsor's protocol ID
- 10002298
- Other IDs
- 002298-H
- Status last verified
- 29 Jul 2026
- First submitted
- 21 Aug 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: See DMSP
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Volunteers, Longitudinal and Multi-omic Study
- ClinicalTrials.gov ID
- NCT07137429
- Acronym / sponsor ID
- 10002298
- Conditions
- Thrombosis
- Keywords
- PLATELET FUNCTION, Platelet biology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 15 Sep 2041 (estimated)
- Study completion
- 15 Sep 2041 (estimated)
- First posted
- 22 Aug 2025 (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.
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.
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)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy participants, at least 18 years of age |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants, at least 18 years of age
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish and validate technical assays and equipment (e.g. platelet aggregation, hemostasis measurements, methylation, RNA-seq, proteomics and WGS, in vitro iPSC.
Time frame: 10 years
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.
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.
Time frame: 10 years
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.
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 31 Jul 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. See DMSP
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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.
Andrew D Johnson, Ph.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jayson J Grey, R.N. ((240) 401-6378, jayson.grey@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish and validate technical assays and equipment (e.g. platelet aggregation, hemostasis measurements, methylation, RNA-seq, proteomics and WGS, in vitro iPSC. (time frame: 10 years). The study lists 2 primary outcomes in all. 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 31 Jul 2026.