The Role of Microparticles as a Biomarker

Thrombotic Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02626663
• Other study ID #: RSRB00059370
• Status: Withdrawn
• Start date: July 2016
• Est. completion date: December 2022

Study information

• Verified date: February 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Patients with MAHA, TTP, and/or aHUS

Exclusion Criteria:

• Prisoners

Related Conditions & MeSH terms

• Anemia, Hemolytic
• Atypical Hemolytic Uremic Syndrome
• Azotemia
• Hemolysis
• Hemolytic-Uremic Syndrome
• Microangiopathic Hemolytic Anemia
• Microparticles
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic
• Syndrome
• Thrombotic Thrombocytopenic Purpura

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microparticle/Nanoparticle number (an absolute number)		an average of 3 months
Primary	Microparticle/Nanoparticle size (in nanometers or micrometers)		an average of 3 months
Primary	Microparticle/Nanoparticle identity (identity of cell type from which they are derived)		an average of 3 months
Secondary	Morbidities		3 months
Secondary	Mortality		3 months