Moderate and Severe HaemophiliaNCT03237273
HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound
A study testing HEAD-US scoring system in people with Moderate and Severe Haemophilia, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
Ultrasound represents a promising technique for the assessment of joint health in persons with haemophilia (PWH) by non-imaging specialists. The Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating joint ultrasound in the routine assessment of PWH… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Moderate and Severe Haemophilia
- What is being tested?
- HEAD-US scoring system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2017
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate (FVIII/FIX:C 1-5%) and severe (FVIII/FIX: C <1%) patients with haemophilia A or B aged ≥ 6 years
- On demand or prophylaxis treatment regimen
Who cannot join
- Joints with a previous history of surgery
- Joints with damage as a result of causes other than haemophilia-related bleeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound on Disease Management and Treatment Decision-making in Moderate and Severe Haemophilia
Ultrasound represents a promising technique for the assessment of joint health in persons with haemophilia (PWH) by non-imaging specialists. The Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating joint ultrasound in the routine assessment of PWH through the use of a simplified scoring system. The inter-operator reliability of the technique among European haemophilia treaters has been validated and described elsewhere. Further work is needed to assess the real-world impact of ultrasound on disease management and treatment decision-making.
Read the detailed description
Patients are seen routinely in clinic by specialist haemophilia physiotherapists who assess the patients using the Haemophilia Joint Health Score tool (HJHS). Trial participants will be seen during their routine clinic visits and will be seen by a clinician and the physiotherapist who will carry out the routine assessment along with the HEAD-US scan.
Patients will be seen a maximum of 4 times throughout the year from registration of the first patient, according to their visit schedule, but will only be scanned at the first visit.
Results will be analysed to determine if the treatment decision-making is influenced by the results of the scan
- Conditions
- Moderate and Severe Haemophilia
- Being tested
- HEAD-US scoring system
- Medical subject headings
- Lymphoma, Follicular, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEAD-US scoring systemOther
HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist Receives: Other: HEAD-US scoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any change in treatment
Any change in treatment including, management of a bleed and/or change in routine treatment protocol (including changes to prophylaxis regimen, or decision to start/stop prophylaxis regimen) as a result of the ultrasound findings
Measured: 12 months
Secondary outcomes (2)
% joints with normal HJHS and abnormal HEAD-US score
% joints with normal HJHS and abnormal HEAD-US score (for knees, ankles amd elbows separately
Measured: 12 months
% joints with abnormal HJHS and normal HEAD-US score
% joints with abnormal HJHS and normal HEAD-US score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study startDec 2015
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate and Severe HaemophiliaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Gerard Dolan, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237273
- Sponsor's protocol ID
- 63143
- Status last verified
- Jul 2017
- First submitted
- 31 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be analysed and reported as results not individual data
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound on Disease Management and Treatment Decision-making in Moderate and Severe Haemophilia
- ClinicalTrials.gov ID
- NCT03237273
- Acronym / sponsor ID
- 63143
- Conditions
- Moderate and Severe Haemophilia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Aug 2017 (actual)
- 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.
Ultrasound represents a promising technique for the assessment of joint health in persons with haemophilia (PWH) by non-imaging specialists. The Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating joint ultrasound in the routine assessment of PWH through the use of a simplified scoring system. The inter-operator reliability of the technique among European haemophilia treaters has been validated and described elsewhere. Further work is needed to assess the real-world impact of ultrasound on disease management and treatment decision-making.
Detailed description
Patients are seen routinely in clinic by specialist haemophilia physiotherapists who assess the patients using the Haemophilia Joint Health Score tool (HJHS). Trial participants will be seen during their routine clinic visits and will be seen by a clinician and the physiotherapist who will carry out the routine assessment along with the HEAD-US scan.
Patients will be seen a maximum of 4 times throughout the year from registration of the first patient, according to their visit schedule, but will only be scanned at the first visit.
Results will be analysed to determine if the treatment decision-making is influenced by the results of the scan
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Other: HEAD-US scoring systemAll patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate (FVIII/FIX:C 1-5%) and severe (FVIII/FIX: C <1%) patients with haemophilia A or B aged ≥ 6 years
- On demand or prophylaxis treatment regimen
Key exclusion criteria (2 listed)
- Joints with a previous history of surgery
- Joints with damage as a result of causes other than haemophilia-related bleeding
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 |
|---|---|---|
| HEAD-US scoring systemHEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage | Other | Single |
Primary outcome
Any change in treatment
Time frame: 12 months
Any change in treatment including, management of a bleed and/or change in routine treatment protocol (including changes to prophylaxis regimen, or decision to start/stop prophylaxis regimen) as a result of the ultrasound findings
2 secondary outcomes
% joints with normal HJHS and abnormal HEAD-US score
Time frame: 12 months
% joints with abnormal HJHS and normal HEAD-US score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Individual participant dataSharing planned: No. Data will be analysed and reported as results not individual data
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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.
Gerard Dolan, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing HEAD-US scoring system in people with Moderate and Severe Haemophilia, run by Guy's and St Thomas' NHS Foundation Trust.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Collette Pigden, MSc (020 7188 7188 ext. 52464, collette.pigden@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any change in treatment (time frame: 12 months). 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 2 Aug 2017.