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

International Registry and Biorepository for TMA(Thrombotic Microangiopathy)

This study is currently recruiting participants.
Verified by North Shore Long Island Jewish Health System, January 2008

Sponsors and Collaborators:	North Shore Long Island Jewish Health System 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)
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00593229

Purpose

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

Condition

Thrombotic Microangiopathy
Hemolytic Uremic Syndrome
Thrombotic Thrombocytopenic Purpura

Genetics Home Reference related topics:

thrombotic thrombocytopenic purpura

MedlinePlus related topics:

Anemia Bleeding Disorders Blood and Blood Disorders Kidney Diseases Vascular Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	An Observational Study of All Forms of Thrombotic Microangiopathy in Pediatric Patients

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Serum, plasma, urine, and DNA

Estimated Enrollment:	500
Study Start Date:	January 2007

Groups/Cohorts

Familial atypical HUS

Thrombotic thrombocytopenic purpura (TTP)

Severe diarrhea-associated hemolytic uremic syndrome (D+HUS)

Non-familial atypical HUS

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.

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Pediatric patients, 6 months - 18 years

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593229

Locations


United States, New York
	Schneider Chldren's Hospital	Recruiting
	New Hyde Park, New York, United States, 11040
	Contact: Howard Trachtman, MD 718-470-3423 trachtma@lij.edu
	Contact: Cathy Hoffman, RN 718-470-3499 choffman@nshs.edu
	Principal Investigator: Howard Trachtman, MD

Sponsors and Collaborators

North Shore Long Island Jewish Health System

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


Principal Investigator:	Howard Trachtman, MD	Schneider Children's Hospital

More Information

Responsible Party:	Feinstein Institute for Medical Research of North Shore-LIJ Health System ( Howard Trachtman )
Study ID Numbers:	DK71221, DK R21-71221
First Received:	January 2, 2008
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00593229
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

Thrombotic microangiopathy (TMA)

Hemolytic uremic syndrome (HUS)

Thrombotic thrombocytopenic purpura (TTP)

Study placed in the following topic categories:

Pregnancy Complications

Thrombophilia

Hemostatic Disorders

Purpura, Thrombotic Thrombocytopenic

Purpura, Thrombocytopenic

Hemolytic-Uremic Syndrome

Signs and Symptoms

Thrombocytopenia

Urologic Diseases

Kidney Diseases

Purpura

Hemolytic-uremic syndrome

Hematologic Diseases

Blood Platelet Disorders

Blood Coagulation Disorders

Anemia

Vascular Diseases

Anemia, Hemolytic

Thrombosis

Thrombotic thrombocytopenic purpura, acquired

Additional relevant MeSH terms:

Skin Manifestations

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Hemic and Lymphatic Diseases

Immune System Diseases

Female Urogenital Diseases

Cardiovascular Diseases

Pathological Conditions, Signs and Symptoms

ClinicalTrials.gov processed this record on May 15, 2008