International Registry and Biorepository for TMA(Thrombotic Microangiopathy)
Sponsor
Northwell Health (Other)
Overall Status
Terminated
CT.gov ID
NCT00593229
Collaborator
Children's Hospital of Philadelphia (Other), Mario Negri Institute for Pharmacological Research (Other), Icahn School of Medicine at Mount Sinai (Other), University of Virginia (Other), Montreal Children's Hospital of the MUHC (Other), University of Utah (Other), Stollery Children's Hospital (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
6
1
Study Details
Study Description
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 | Intervention/Treatment | Phase |
---|---|---|
|
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
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
:
Jan 1, 2007
Actual Primary Completion Date
:
Oct 1, 2011
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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
Primary Outcome Measures
- Determine epidemiology and outcomes of the various forms of TMA [Ongoing]
- Determine genetic causes of TMA [Ongoing]
Secondary Outcome Measures
- Initiate clinical trials in TMA [In the future]
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Severe HUS, familial or non-familial atypical HUS, TTP
Exclusion Criteria:
- None
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 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
- Principal Investigator: Howard Trachtman, MD, Schneider Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Northwell Health
ClinicalTrials.gov Identifier:
NCT00593229
Other Study ID Numbers:
- DK71221
- DK R21-71221
First Posted:
Jan 14, 2008
Last Update Posted:
Jun 19, 2013
Last Verified:
Jun 1, 2013
Keywords provided by Northwell Health
Additional relevant MeSH terms: