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International Registry and Biorepository for TMA(Thrombotic Microangiopathy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00593229
Recruitment Status : Terminated (study stopped at this site, as investigator left the institution)
First Posted : January 14, 2008
Last Update Posted : June 19, 2013
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Mario Negri Institute for Pharmacological Research
Icahn School of Medicine at Mount Sinai
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 (Responsible Party):
Northwell Health

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA) annually from pediatric patients with thrombotic mcroangiopathy

Condition or disease
Thrombotic Microangiopathy Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura

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 Design
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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Study of All Forms of Thrombotic Microangiopathy in Pediatric Patients
Study Start Date : January 2007
Actual Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
3
Familial atypical HUS
4
Thrombotic thrombocytopenic purpura (TTP)
1
Severe diarrhea-associated hemolytic uremic syndrome (D+HUS)
2
Non-familial atypical HUS


Outcome Measures
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Primary Outcome Measures :
  1. Determine epidemiology and outcomes of the various forms of TMA [ Time Frame: Ongoing ]
  2. Determine genetic causes of TMA [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. Initiate clinical trials in TMA [ Time Frame: In the future ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, urine, and DNA

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593229


Locations
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United States, New York
Schneider Chldren's Hospital
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Children's Hospital of Philadelphia
Mario Negri Institute for Pharmacological Research
Icahn School of Medicine at Mount Sinai
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
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Principal Investigator: Howard Trachtman, MD Schneider Children's Hospital
More Information
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Additional Information:

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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT00593229    
Other Study ID Numbers: DK71221
DK R21-71221
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by Northwell Health:
Thrombotic microangiopathy (TMA)
Hemolytic uremic syndrome (HUS)
Thrombotic thrombocytopenic purpura (TTP)
Additional relevant MeSH terms:
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Hemolytic-Uremic Syndrome
Vascular Diseases
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Thrombotic Microangiopathies
Hemolysis
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Skin Manifestations
Thrombocytopenia
 Blood Platelet Disorders
Immune System Diseases
Uremia
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Thrombophilia
Anemia, Hemolytic
Anemia
Cardiovascular Diseases