International Registry and Biorepository for TMA(Thrombotic Microangiopathy) - Tabular View

Tracking Information

First Received Date ^ICMJE

January 2, 2008

Last Updated Date

August 4, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Determine epidemiology and outcomes of the various forms of TMA [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Determine genetic causes of TMA [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00593229 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Initiate clinical trials in TMA [ Time Frame: In the future ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

International Registry and Biorepository for TMA(Thrombotic Microangiopathy)

Official Title ^ICMJE

An Observational Study of All Forms of Thrombotic Microangiopathy in Pediatric Patients

Brief Summary

This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA) annually from pediatric patients with thrombotic mcroangiopathy

Detailed Description

Children age, 6 months - 18 years, are eligible if they have one of the following categories of thrombotic microangiopathy (TMA):(1) severe D+HUS; (2) non-familial atypical HUS; (3) familial atypical HUS; or (4) TTP

Patients are seen intially and annually thereafter

Biosamples are collected for storage annually.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Thrombotic Microangiopathy
Hemolytic Uremic Syndrome
Thrombotic Thrombocytopenic Purpura

Intervention ^ICMJE

Study Arms / Comparison Groups

Familial atypical HUS
Thrombotic thrombocytopenic purpura (TTP)
Severe diarrhea-associated hemolytic uremic syndrome (D+HUS)
Non-familial atypical HUS

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Severe HUS, familial or non-familial atypical HUS, TTP

Exclusion Criteria:

None

Gender

Both

Ages

6 Months to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Howard Trachtman, MD

718-470-3423

trachtma@lij.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00593229

Responsible Party

Howard Trachtman, Feinstein Institute for Medical Research of North Shore-LIJ Health System

Study ID Numbers ^ICMJE

DK71221, DK R21-71221

Study Sponsor ^ICMJE

North Shore Long Island Jewish Health System

Collaborators ^ICMJE

Children's Hospital of Philadelphia
Mario Negri Institute for Pharmacological Research
Mount Sinai School of Medicine
University of Virginia
Montreal Children's Hospital of the MUHC
University of Utah
Stollery Children's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Howard Trachtman, MD

Schneider Children's Hospital

Information Provided By

North Shore Long Island Jewish Health System

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP