Clincosm LogoSign in Get a demo

The Role of Microparticles as a Biomarker

Sponsor
University of Rochester (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02626663
Collaborator
(none)
0
Enrollment
1
Location
77
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Role of Microparticles as a Biomarker in Distinguishing Between Thrombotic Thrombocytopenic Purpura (TTP) and Atypical Hemolytic Uremic Syndrome (aHUS)
    Study Start Date :
    Jul 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    aHUS

    atypical Hemolytic Uremic Syndrome
    TTP

    Thrombotic thrombocytopenic purpura
    MAHA

    other microangiopathic hemolytic anemias

    Outcome Measures

    Primary Outcome Measures

    1. Microparticle/Nanoparticle number (an absolute number) [an average of 3 months]

    2. Microparticle/Nanoparticle size (in nanometers or micrometers) [an average of 3 months]

    3. Microparticle/Nanoparticle identity (identity of cell type from which they are derived) [an average of 3 months]

    Secondary Outcome Measures

    1. Morbidities [3 months]

    2. Mortality [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with MAHA, TTP, and/or aHUS
    Exclusion Criteria:
    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Medical Center Rochester New York United States

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    • Principal Investigator: Amy Schmidt, MD PhD, University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Majed Refaai, Associate Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT02626663
    Other Study ID Numbers:
    • RSRB00059370
    First Posted:
    Dec 10, 2015
    Last Update Posted:
    Feb 19, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Hemolytic-Uremic Syndrome
    Atypical Hemolytic Uremic Syndrome
    Purpura
    Purpura, Thrombocytopenic
    Anemia, Hemolytic
    Purpura, Thrombotic Thrombocytopenic
    Hemolysis

    Study Results

    No Results Posted as of Feb 19, 2019