SonographyNCT04550988
Sonography and Haemophilia
An observational study of Sonography and Haemophilia, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device: The following questions will be answered: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sonography, Haemophilia
- What is being tested?
- feasibility study
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2021to 31 Dec 2022
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B. Haemophilia is an X-linked recessive genetic bleeding disease characterised by absence or deficiency of factor VIII in haemophilia A or factor IX in haemophilia B. This can cause spontaneous bleedings, particularly into joints. Joint bleedings initiate an inflammatory process characterised by chronic synovitis that causes degeneration of the affected joints and results in haemophilic arthropathy
Who may be able to join
- Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B
- No professional medical background
- Submitted written consent to participate in the study and to use their study related pseudonymized data
Who cannot join
- Patients suffering from other bleeding diseases
- Participants < 18 years of age
- Participants without written consent
- Professional medical background
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Bonn
Bonn, Northrhine Westfalia, 53127
Andreas Strauß, PD Dr.
Andreas Strauß, PD Dr.
About this study
Official title: Self-conducted Sonographic Monitoring of the Target Joints in Patients With Severe Haemophilia
The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device:
The following questions will be answered:
- What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia?
- Is it possible to train patients with haemophilia to perform sonography of their target joints?
- Does a patient-based ultrasound monitoring with a handheld device work in a home setting?
- What is the quality of the patient's self-acquired ultrasound images?
- Will the test persons be able to distinguish normal findings from (any) pathologic findings?
- Conditions
- Sonography, Haemophilia
- Being tested
- feasibility study
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feasibility studyOther
The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with severe haemophilia A or B | * Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B
* No professional medical background
* Submitted written consent to participate in the study and to use their study related pseudonymised data Receives: Other: feasibility study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Anterior mid-sagittal ultrasound image.
Patella, distal femur, suprapatellar recess, suprapatellar fat pad and prefemoral fat pad must be visible.
Measured: 5 min
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Anterolateral transverse ultrasound image.
Patellofemoral joint, lateral parapatellar recess, lateral patellar retinaculum and lateral femoral condyle must be visible.
Measured: 5 min
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Transverse ultrasound image - Transverse ultrasound image
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Transverse ultrasound image.
Medial facets of the trochlea, lateral facets of the trochlea and cartilage must be visible.
Measured: 5min
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Coronal ultrasound image
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Coronal ultrasound image.
Medial meniscus, boundaries of the femur, boundaries of the tibia must be visible.
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start8 Feb 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SonographyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Responsible party
- Principal investigator, PD Dr. Andreas Strauß, University Hospital, Bonn
- Investigators
- Andreas Strauß, PD Dr., Principal investigator, Medicine of the University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550988
- Sponsor's protocol ID
- POD10816
- Status last verified
- May 2022
- First submitted
- 25 Aug 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The publication of anonymous patient data is not allowed by informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-conducted Sonographic Monitoring of the Target Joints in Patients With Severe Haemophilia
- ClinicalTrials.gov ID
- NCT04550988
- Acronym / sponsor ID
- POD10816
- Conditions
- Sonography, Haemophilia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Sep 2020 (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.
The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device:
The following questions will be answered:
- What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia?
- Is it possible to train patients with haemophilia to perform sonography of their target joints?
- Does a patient-based ultrasound monitoring with a handheld device work in a home setting?
- What is the quality of the patient's self-acquired ultrasound images?
- Will the test persons be able to distinguish normal findings from (any) pathologic findings?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with severe haemophilia A or B | – | Other: feasibility study* Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B * No professional medical background * Submitted written consent to participate in the study and to use their study related pseudonymised data |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B. Haemophilia is an X-linked recessive genetic bleeding disease characterised by absence or deficiency of factor VIII in haemophilia A or factor IX in haemophilia B. This can cause spontaneous bleedings, particularly into joints. Joint bleedings initiate an inflammatory process characterised by chronic synovitis that causes degeneration of the affected joints and results in haemophilic arthropathy
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B
- No professional medical background
- Submitted written consent to participate in the study and to use their study related pseudonymized data
Key exclusion criteria (4 listed)
- Patients suffering from other bleeding diseases
- Participants < 18 years of age
- Participants without written consent
- Professional medical background
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 |
|---|---|---|
| feasibility studyThe aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device. | Other | Adult patients with severe haemophilia A or B |
Primary outcome
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image
Time frame: 5 min
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Anterior mid-sagittal ultrasound image. Patella, distal femur, suprapatellar recess, suprapatellar fat pad and prefemoral fat pad must be visible.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image
Time frame: 5 min
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Anterolateral transverse ultrasound image. Patellofemoral joint, lateral parapatellar recess, lateral patellar retinaculum and lateral femoral condyle must be visible.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Transverse ultrasound image - Transverse ultrasound image
Time frame: 5min
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Transverse ultrasound image. Medial facets of the trochlea, lateral facets of the trochlea and cartilage must be visible.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Coronal ultrasound image
Time frame: 5 min
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Coronal ultrasound image. Medial meniscus, boundaries of the femur, boundaries of the tibia must be visible.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No. The publication of anonymous patient data is not allowed by informed consent.
Related trials for Sonography
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
Not yet recruiting
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
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.
Andreas Strauß, PD Dr. principal investigator
Medicine of the University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sonography and Haemophilia, run by University Hospital, Bonn at 1 site in Germany.
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 3 inclusion and 4 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 19 May 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Strauß, PD Dr. (004922828714176, andreas.strauss@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image (time frame: 5 min). The study lists 4 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 19 May 2022.