Sonography and Haemophilia

Haemophilia Clinical Trial

Official title:

Self-conducted Sonographic Monitoring of the Target Joints in Patients With Severe Haemophilia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550988
• Other study ID #: POD10816
• Status: Recruiting
• Start date: February 8, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Bonn
• Contact: Andreas Strauß, PD Dr.
• Phone: 004922828714176
• Email: andreas.strauss[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A
• Sonography

Intervention

Other:
• feasibility study
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.

Locations

Country	Name	City	State
Germany	University Hospital of Bonn	Bonn	Northrhine Westfalia

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Swedish Orphan Biovitrum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 min
Primary	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.	5 min
Primary	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.	5min
Primary	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.	5 min