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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

Tracking Information
First Submitted Date January 2, 2008
First Posted Date January 14, 2008
Last Update Posted Date June 19, 2013
Study Start Date January 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2008)
  • Determine epidemiology and outcomes of the various forms of TMA [ Time Frame: Ongoing ]
  • Determine genetic causes of TMA [ Time Frame: Ongoing ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 11, 2008)		 Initiate clinical trials in TMA [ Time Frame: In the future ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, plasma, urine, and DNA
Sampling Method Non-Probability Sample
Study Population Pediatric patients, 6 months - 18 years
Condition
  • Thrombotic Microangiopathy
  • Hemolytic Uremic Syndrome
  • Thrombotic Thrombocytopenic Purpura
Intervention Not Provided
Study Groups/Cohorts
  • 3
    Familial atypical HUS
  • 4
    Thrombotic thrombocytopenic purpura (TTP)
  • 1
    Severe diarrhea-associated hemolytic uremic syndrome (D+HUS)
  • 2
    Non-familial atypical HUS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 18, 2013)		 6
Original Estimated Enrollment
 (submitted: January 11, 2008)		 500
Study Completion Date Not Provided
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00593229
Other Study ID Numbers DK71221
DK R21-71221
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Northwell Health
Original Responsible Party Howard Trachtman, Feinstein Institute for Medical Research of North Shore-LIJ Health System
Current Study Sponsor Northwell Health
Original Study Sponsor Same as current
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)
Investigators
Principal Investigator: Howard Trachtman, MD Schneider Children's Hospital
PRS Account Northwell Health
Verification Date June 2013