The Role of Microparticles as a Biomarker

February 15, 2019 updated by: Majed Refaai, University of Rochester

The Role of Microparticles as a Biomarker in Distinguishing Between Thrombotic Thrombocytopenic Purpura (TTP) and Atypical Hemolytic Uremic Syndrome (aHUS)

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with Microangiopathic Hemolytic Anemias (MAHA), TTP, and/or aHUS are eligible.

Description

Inclusion Criteria:

  • Patients with MAHA, TTP, and/or aHUS

Exclusion Criteria:

  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
aHUS
atypical Hemolytic Uremic Syndrome
TTP
Thrombotic thrombocytopenic purpura
MAHA
other microangiopathic hemolytic anemias

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Microparticle/Nanoparticle number (an absolute number)
Time Frame: an average of 3 months
an average of 3 months
Microparticle/Nanoparticle size (in nanometers or micrometers)
Time Frame: an average of 3 months
an average of 3 months
Microparticle/Nanoparticle identity (identity of cell type from which they are derived)
Time Frame: an average of 3 months
an average of 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidities
Time Frame: 3 months
3 months
Mortality
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB00059370

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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