Inherited Bleeding DisordersNCT00212485
Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease
A study testing Power Doppler Sonography and MRI in people with Inherited Bleeding Disorders, run by New York Presbyterian Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Inherited Bleeding Disorders
- What is being tested?
- Power Doppler Sonography and MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital/Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease
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.
Read the 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.
- Conditions
- Inherited Bleeding Disorders
- Being tested
- Power Doppler Sonography, MRI
- Keywords
- Hemophilia, Factor Deficiency, synovitis, sonogram
- Medical subject headings
- Hemophilia A, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Doppler SonographyProcedure or surgery
Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.
MRIProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint
Measured: Up to 1 month
Evaluation of PDS on patients with target joints pre and post synovectomy to assess response to therapeutic intervention
Measured: 1. day of synovectomy; 2. 6 months post synovectomy.
Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Bleeding DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Suchitra S Acharya, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212485
- Sponsor's protocol ID
- PDS
- Status last verified
- Jun 2010
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease
- ClinicalTrials.gov ID
- NCT00212485
- Acronym / sponsor ID
- PDS
- Conditions
- Inherited Bleeding Disorders
- Keywords
- Hemophilia, Factor Deficiency, synovitis, sonogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Diagnosis of inherited bleeding disorder
- 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
- Meet inclusion criteria for Aim 1 and will be having a synovectomy
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power Doppler SonographyPower Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints. | Procedure or surgery | – |
| MRIMagnetic Resonance Imaging with intravenous gadolinium contrast will be done using a standardized protocol, including a spin echo T2 weighted image and gradient echo images. | Procedure or surgery | – |
Primary outcome
Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint
Time frame: Up to 1 month
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.
Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suchitra S Acharya, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Doppler Sonography and MRI in people with Inherited Bleeding Disorders, run by New York Presbyterian Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint (time frame: Up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2010.