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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) |
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Information provided by: | North Shore Long Island Jewish Health System |
ClinicalTrials.gov Identifier: | NCT00593229 |
This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA) annually from pediatric patients with thrombotic mcroangiopathy
Condition |
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Thrombotic Microangiopathy Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | An Observational Study of All Forms of Thrombotic Microangiopathy in Pediatric Patients |
Serum, plasma, urine, and DNA
Estimated Enrollment: | 60 |
Study Start Date: | January 2007 |
Groups/Cohorts |
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3
Familial atypical HUS
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4
Thrombotic thrombocytopenic purpura (TTP)
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1
Severe diarrhea-associated hemolytic uremic syndrome (D+HUS)
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2
Non-familial atypical HUS
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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.
Ages Eligible for Study: | 6 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Pediatric patients, 6 months - 18 years
Inclusion Criteria:
Exclusion Criteria:
Contact: Howard Trachtman, MD | 718-470-3423 | trachtma@lij.edu |
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 |
Principal Investigator: | Howard Trachtman, MD | Schneider Children's Hospital |
Responsible Party: | Feinstein Institute for Medical Research of North Shore-LIJ Health System ( Howard Trachtman ) |
Study ID Numbers: | DK71221, DK R21-71221 |
Study First Received: | January 2, 2008 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00593229 History of Changes |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Thrombotic microangiopathy (TMA) Hemolytic uremic syndrome (HUS) Thrombotic thrombocytopenic purpura (TTP) |
Purpura Azotemia Hematologic Diseases Thrombophilia Blood Coagulation Disorders Blood Platelet Disorders Vascular Diseases Anemia Anemia, Hemolytic Thrombotic Thrombocytopenic Purpura, Acquired Hemostatic Disorders Purpura, Thrombotic Thrombocytopenic |
Hemolytic-Uremic Syndrome Purpura, Thrombocytopenic Thrombosis Thrombocytopathy Signs and Symptoms Embolism and Thrombosis Thrombocytopenia Urologic Diseases Embolism Uremia Kidney Diseases Hemolytic-uremic Syndrome |
Skin Manifestations Thrombophilia Purpura, Thrombotic Thrombocytopenic Purpura, Thrombocytopenic Hemolytic-Uremic Syndrome Signs and Symptoms Thrombocytopenia Pathologic Processes Urologic Diseases Syndrome Cardiovascular Diseases Kidney Diseases Azotemia |
Purpura Disease Immune System Diseases Hematologic Diseases Blood Platelet Disorders Blood Coagulation Disorders Anemia Vascular Diseases Anemia, Hemolytic Thrombosis Embolism and Thrombosis Uremia |