Platelet Volunteers, Longitudinal and Multi-omic Study

Not yet recruiting

• Conditions: Thrombosis

• Registration Number: NCT07137429
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief 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.

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 Timeline

• Study First Submitted: 2025-08-21
• Study First Submitted QC: 2025-08-21
• Study First Posted: 2025-08-22
• Status Verified: 2025-08-28
• Last Update Submitted: 2025-10-02
• Last Update Posted: 2025-10-03
• Study Start: 2025-10-08
• Primary Completion: 2041-09-15
• Study Completion: 2041-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States