Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study

This study is currently recruiting participants.

Verified November 2012 by University of California, Davis

Sponsor:

Collaborator:

The Slovenian Ministry of Higher Education, Science and Technology

Information provided by (Responsible Party):

Lavjay Butani, MD, University of California, Davis

ClinicalTrials.gov Identifier:

NCT00616317

First received: February 4, 2008

Last updated: November 30, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 4, 2008

Last Updated Date

November 30, 2012

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Long term survival [ Time Frame: 10 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00616317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Official Title ^ICMJE

Brief Summary

The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Pediatric Nephrology Clinic at University of California, Davis

Condition ^ICMJE

Antiphospholipid Syndrome

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years of age or younger at the onset of disease
Presence of Vascular Thrombosis
UC Davis patient
Presence of at least one Laboratory criteria including: Anticardiolipin antibody, Anti-B glycoprotein-I antibody or Lupus anticoagulant in plasma

Exclusion Criteria:

Infants born to mothers with APS
Infants with congenital thrombophilia

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Lavjay Butani

(916) 734-8118

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00616317

Other Study ID Numbers ^ICMJE

200614666-1

Has Data Monitoring Committee

Responsible Party

Lavjay Butani, MD, University of California, Davis

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

The Slovenian Ministry of Higher Education, Science and Technology

Investigators ^ICMJE

Principal Investigator:

Lavjay Butani, M.D.

University of California, Davis

Information Provided By

University of California, Davis

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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