Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
400 participants
OBSERVATIONAL
2025-11-13
2041-09-15
Brief Summary
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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
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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
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Healthy
Healthy participants, at least 18 years of age
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Andrew D Johnson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
Sarah Margarette Deguzman
Role: backup
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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002298-H
Identifier Type: -
Identifier Source: secondary_id
10002298
Identifier Type: -
Identifier Source: org_study_id