We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

International Registry and Biorepository for TMA(Thrombotic Microangiopathy)

This study has been terminated.
(study stopped at this site, as investigator left the institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593229
First Posted: January 14, 2008
Last Update Posted: June 19, 2013
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.
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
  Purpose
This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA) annually from pediatric patients with thrombotic mcroangiopathy

Condition
Thrombotic Microangiopathy Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Study of All Forms of Thrombotic Microangiopathy in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Northwell Health:

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

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

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

Enrollment: 6
Study Start Date: January 2007
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:

  Contacts and Locations
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
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
Principal Investigator: Howard Trachtman, MD Schneider Children's Hospital
  More Information

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT00593229     History of Changes
Other Study ID Numbers: DK71221
DK R21-71221
First Submitted: January 2, 2008
First Posted: January 14, 2008
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:
Hemolytic-Uremic Syndrome
Purpura
Purpura, Thrombocytopenic
Hemolysis
Purpura, Thrombotic Thrombocytopenic
Vascular Diseases
Thrombotic Microangiopathies
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Thrombophilia
Cardiovascular Diseases