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The Role of Microparticles as a Biomarker

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ClinicalTrials.gov Identifier: NCT02626663
Recruitment Status : Withdrawn (PI left the University, sponsor pulled funding)
First Posted : December 10, 2015
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Majed Refaai, University of Rochester

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
Atypical Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura Microparticles Microangiopathic Hemolytic Anemia

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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 : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022


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



Primary Outcome Measures :
  1. Microparticle/Nanoparticle number (an absolute number) [ Time Frame: an average of 3 months ]
  2. Microparticle/Nanoparticle size (in nanometers or micrometers) [ Time Frame: an average of 3 months ]
  3. Microparticle/Nanoparticle identity (identity of cell type from which they are derived) [ Time Frame: an average of 3 months ]

Secondary Outcome Measures :
  1. Morbidities [ Time Frame: 3 months ]
  2. Mortality [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
platelet poor plasma samples will be retained. These samples will contain Microparticles and nanoparticles as well as microRNA.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with Microangiopathic Hemolytic Anemias (MAHA), TTP, and/or aHUS are eligible.
Criteria

Inclusion Criteria:

  • Patients with MAHA, TTP, and/or aHUS

Exclusion Criteria:

  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626663


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Amy Schmidt, MD PhD University of Rochester

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Responsible Party: Majed Refaai, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02626663     History of Changes
Other Study ID Numbers: RSRB00059370
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Purpura
Purpura, Thrombocytopenic
Anemia, Hemolytic
Purpura, Thrombotic Thrombocytopenic
Syndrome
Hemolysis
Disease
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Uremia
Kidney Diseases
Urologic Diseases
Anemia
Thrombophilia