NCT00593229

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4.8 years

First QC Date

January 2, 2008

Last Update Submit

June 18, 2013

Conditions

Thrombotic MicroangiopathyHemolytic Uremic SyndromeThrombotic Thrombocytopenic Purpura

Keywords

Thrombotic microangiopathy (TMA)Hemolytic uremic syndrome (HUS)Thrombotic thrombocytopenic purpura (TTP)

Outcome Measures

Primary Outcomes (2)

  • Determine epidemiology and outcomes of the various forms of TMA

    Ongoing

  • Determine genetic causes of TMA

    Ongoing

Secondary Outcomes (1)

  • Initiate clinical trials in TMA

    In the future

Study Arms (4)

3

Familial atypical HUS

4

Thrombotic thrombocytopenic purpura (TTP)

1

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

2

Non-familial atypical HUS

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients, 6 months - 18 years

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Chldren's Hospital

New Hyde Park, New York, 11040, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, urine, and DNA

MeSH Terms

Conditions

Thrombotic MicroangiopathiesHemolytic-Uremic SyndromePurpura, Thrombotic Thrombocytopenic

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaUremiaKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAnemia, HemolyticAnemiaPurpura, ThrombocytopenicPurpuraBlood Coagulation DisordersThrombophiliaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Howard Trachtman, MD

    Schneider Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

January 1, 2007

Primary Completion

October 1, 2011

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)