International Registry and Biorepository for TMA(Thrombot... | NCT00593229

Studies
International Registry and Biorepository for TMA(Thrombotic Microangiopathy)

NCT00593229

Sponsor

Northwell Health

Status

Terminated

Last Update Posted

Jun 19, 2013Estimated

Enrollment

6Actual

Phase

Not provided

Conditions

Thrombotic Microangiopathy
Hemolytic Uremic Syndrome
Thrombotic Thrombocytopenic Purpura

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DK R21-71221

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study stopped at this site, as investigator left the institution

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Oct 2011Actual

Completion Date

Not provided

First Submitted Date

Jan 2, 2008

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Name	Class
Children's Hospital of Philadelphia	OTHER
Mario Negri Institute for Pharmacological Research	OTHER
Icahn School of Medicine at Mount Sinai	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3		Familial atypical HUS
4		Thrombotic thrombocytopenic purpura (TTP)
1		Severe diarrhea-associated hemolytic uremic syndrome (D+HUS)
2		Non-familial atypical HUS

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine epidemiology and outcomes of the various forms of TMA		Ongoing
Determine genetic causes of TMA		Ongoing

Secondary Outcomes

Measure	Description	Time Frame
Initiate clinical trials in TMA		In the future

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric patients, 6 months - 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Howard Trachtman, MD	Schneider Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schneider Chldren's Hospital		New Hyde Park	New York	11040	United States

Condition Browse Module

MeSH Terms

ID	Term
D057049	Thrombotic Microangiopathies
D006463	Hemolytic-Uremic Syndrome
D011697	Purpura, Thrombotic Thrombocytopenic

Ancestor Terms

ID	Term
D013921	Thrombocytopenia
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided