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International Registry and Biorepository for TMA(Thrombotic Microangiopathy)

This study is enrolling participants by invitation only.
Sponsor:
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)
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00593229
First received: January 2, 2008
Last updated: July 9, 2010
Last verified: July 2010
History of Changes

January 2, 2008
July 9, 2010
January 2007
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT00593229 on ClinicalTrials.gov Archive Site
Initiate clinical trials in TMA [ Time Frame: In the future ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
International Registry and Biorepository for TMA(Thrombotic Microangiopathy)
An Observational Study of All Forms of Thrombotic Microangiopathy in Pediatric Patients

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

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, plasma, urine, and DNA
Non-Probability Sample

Pediatric patients, 6 months - 18 years
  • Thrombotic Microangiopathy
  • Hemolytic Uremic Syndrome
  • Thrombotic Thrombocytopenic Purpura
Not Provided
  • 3
    Familial atypical HUS
  • 4
    Thrombotic thrombocytopenic purpura (TTP)
  • 1
    Severe diarrhea-associated hemolytic uremic syndrome (D+HUS)
  • 2
    Non-familial atypical HUS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
Not Provided
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
6 Months to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00593229
DK71221, DK R21-71221
No
Howard Trachtman, Feinstein Institute for Medical Research of North Shore-LIJ Health System
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
North Shore Long Island Jewish Health System
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP