The Role of Microparticles as a Biomarker

NCT02626663 | Withdrawn

• 1 other identifier: RSRB00059370
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atypical Hemolytic Uremic Syndrome; Thrombotic Thrombocytopenic Purpura; Microparticles; Microangiopathic Hemolytic Anemia

Outcome Measures

Primary Outcomes (3)

• Microparticle/Nanoparticle number (an absolute number)

  an average of 3 months

• Microparticle/Nanoparticle size (in nanometers or micrometers)

  an average of 3 months

• Microparticle/Nanoparticle identity (identity of cell type from which they are derived)

  an average of 3 months

Secondary Outcomes (2)

• Morbidities

  3 months

• Mortality

  3 months

Study Arms (3)

aHUS

atypical Hemolytic Uremic Syndrome

TTP

Thrombotic thrombocytopenic purpura

MAHA

other microangiopathic hemolytic anemias

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with MAHA, TTP, and/or aHUS

You may not qualify if:

• Prisoners

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

platelet poor plasma samples will be retained. These samples will contain Microparticles and nanoparticles as well as microRNA.

MeSH Terms

Conditions

Atypical Hemolytic Uremic Syndrome; Purpura, Thrombotic Thrombocytopenic; Anemia, Hemolytic

Condition Hierarchy (Ancestors)

Hemolytic-Uremic Syndrome; Uremia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Thrombophilia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Amy Schmidt, MD PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: December 10, 2015
• Study Start: July 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

US (1)