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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) |
| 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 |
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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 |
| 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: | 500 |
| 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.
Eligibility
| 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:
Contacts and 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 | |||||
| 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) |
| 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 |
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