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| Descriptive Information Fields | |||||
| Brief Title † | International Registry and Biorepository for TMA(Thrombotic Microangiopathy) | ||||
| Official Title † | 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 |
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| 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. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Case-Only, Prospective | ||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | Initiate clinical trials in TMA [ Time Frame: In the future ] [ Designated as safety issue: Yes ] | ||||
| Condition † | Thrombotic Microangiopathy Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura |
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| Intervention † | |||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 500 | ||||
| Start Date † | January 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Months to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00593229 | ||||
| Organization ID | DK71221 | ||||
| Secondary IDs †† | DK R21-71221 | ||||
| Study Sponsor † | North Shore Long Island Jewish Health System | ||||
| Collaborators †† | 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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| Investigators † |
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| Information Provided By | North Shore Long Island Jewish Health System | ||||
| Verification Date | January 2008 | ||||
| First Received Date † | January 2, 2008 | ||||
| Last Updated Date | January 11, 2008 | ||||
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