Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease - Full Text View

Sponsor:	New York Presbyterian Hospital
Collaborator:	Bayer
Information provided by:	New York Presbyterian Hospital
ClinicalTrials.gov Identifier:	NCT00212485

Purpose

The purpose of this study is to see whether power Doppler sonography (PDS) can be used to diagnose synovitis in patients with inherited bleeding disorders.

Condition	Intervention
Inherited Bleeding Disorders	Procedure: Power Doppler Sonography Procedure: MRI

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia Help Me Understand Genetics

MedlinePlus related topics: Bleeding Disorders Joint Disorders MRI Scans Ultrasound

U.S. FDA Resources

Further study details as provided by New York Presbyterian Hospital:

Primary Outcome Measures:

Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
Evaluation of PDS on patients with target joints pre and post synovectomy to assess response to therapeutic intervention [ Time Frame: 1. day of synovectomy; 2. 6 months post synovectomy. ] [ Designated as safety issue: No ]
Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	September 2005
Study Completion Date:	May 2009
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.

Magnetic Resonance Imaging with intravenous gadolinium contrast will be done using a standardized protocol, including a spin echo T2 weighted image and gradient echo images.

Detailed Description:

Aim #1 - To determine if PDS can be used to diagnose synovial hypertrophy and inflammation in joint disease associated with inherited bleeding disorders. MRI will be used as a reference standard.

Aim #2 - To determine if PDS can be used to assess therapeutic response to treatment.

Aim #3 - To determine if PDS can be used as a screening tool for diagnosing early synovitis.

Eligibility

Ages Eligible for Study:	1 Year to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of inherited bleeding disorder

For Aim 1:

Age of at least 6 years
History of at least 4 bleeds in the same joint in the preceding 6 months
Joint swelling, synovitis or deformity

For Aim 2:

Meet inclusion criteria for Aim 1 and will be having a synovectomy

For Aim 3:

Age of at least 1 year
Have had at least 2 joint bleeds

Exclusion Criteria:

Not meeting inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212485

Locations

United States, New York
New York Presbyterian Hospital/Hospital for Special Surgery
New York, New York, United States, 10021

Sponsors and Collaborators

New York Presbyterian Hospital

Bayer

Investigators

Principal Investigator:

Suchitra S Acharya, MD

Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	Suchitra Acharya, MD, New York Presbyterian Hospital
ClinicalTrials.gov Identifier:	NCT00212485 History of Changes
Other Study ID Numbers:	PDS
Study First Received:	September 13, 2005
Last Updated:	June 30, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by New York Presbyterian Hospital:

Hemophilia
Factor Deficiency
synovitis
sonogram

Additional relevant MeSH terms:

Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Joint Diseases

Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 12, 2012