International Registry and Biorepository for TMA(Thrombotic Microangiopathy)

NCT ID: NCT00593229

Last Updated: 2013-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Thrombotic Microangiopathy Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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3

Familial atypical HUS

No interventions assigned to this group

4

Thrombotic thrombocytopenic purpura (TTP)

No interventions assigned to this group

1

Severe diarrhea-associated hemolytic uremic syndrome (D+HUS)

No interventions assigned to this group

2

Non-familial atypical HUS

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role collaborator

Montreal Children's Hospital of the MUHC

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

Stollery Children's Hospital

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Trachtman, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Hospital

Locations

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Schneider Chldren's Hospital

New Hyde Park, New York, United States

Site Status

Countries

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United States

Other Identifiers

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DK R21-71221

Identifier Type: -

Identifier Source: secondary_id

DK71221

Identifier Type: -

Identifier Source: org_study_id

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