Clinical trial NCT04550988: Sonography and Haemophilia
Official title: Self-conducted Sonographic Monitoring of the Target Joints in Patients With Severe Haemophilia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sonography
Haemophilia
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Swedish Orphan Biovitrum
First posted: 2020-09-16
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia?
2. Is it possible to train patients with haemophilia to perform sonography of their target joints?
3. Does a patient-based ultrasound monitoring with a handheld device work in a home setting?
4. What is the quality of the patient's self-acquired ultrasound images?
5. Will the test persons be able to distinguish normal findings from (any) pathologic findings?


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients suffering from other bleeding diseases
* Participants \< 18 years of age
* Participants without written consent
* Professional medical background

Primary outcomes:
measure: Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image
timeFrame: 5 min
measure: Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image
timeFrame: 5 min
measure: Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Transverse ultrasound image - Transverse ultrasound image
timeFrame: 5min
measure: Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Coronal ultrasound image
timeFrame: 5 min
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital of Bonn
state: Northrhine Westfalia
Study officials:
affiliation: Medicine of the University of Bonn
name: Andreas Strauß, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: