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Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05628974
Collaborator
National Institutes of Health (NIH) (NIH)
400
Enrollment
1
Location
133.9
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center study at the Cleveland Clinic Main Campus designed to study biomarkers in healthy individuals to identify novel mechanisms of platelet activation and how platelets drive vascular inflammation and thrombosis in diseases.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Our past studies have discovered novel platelet activation pathways that may be targets of therapeutic development. We have also defined an important role for a shift in platelet phenotype in vascular disease. Our studies use both in vivo animal models and validation using human platelets from isolated blood. Platelets from healthy individuals may be compared to patients with vascular diseases in the IRB approved protocol "Vascular Lab Resource" (IRB #19-1451) study which is actively recruiting patients at the Cleveland Clinic Main Campus and studies patients with vascular diseases.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)
    Actual Study Start Date :
    May 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2030
    Anticipated Study Completion Date :
    Jun 30, 2031

    Outcome Measures

    Primary Outcome Measures

    1. To collect blood samples [10 years]

      To establish a biorepository for normal healthy cohort of subjects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Adults aged 18 to 65 years old

    • Healthy Male & Female voluntary participants

    Exclusion Criteria:

    • Individuals who have taken anticoagulant or antiplatelet medications in past 10 days

    • Individuals with hematopoetic diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Scott Cameron, MD, PhD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Scott Cameron, MD, PhD, Principal Investigator, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT05628974
    Other Study ID Numbers:
    • 20-413
    First Posted:
    Nov 29, 2022
    Last Update Posted:
    Nov 29, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 29, 2022