Sonography and Haemophilia

• Conditions: Haemophilia; Sonography
• Interventions: Other: feasibility study

• Registration Number: NCT04550988
• Lead Sponsor: University Hospital, Bonn

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-16
• Study Start: 2021-02-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients with severe haemophilia A or B	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

Primary Outcome Measures

Name	Time	Method
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image	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 - Coronal ultrasound image	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.
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image	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 - Transverse ultrasound image - Transverse ultrasound image	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.

Trial Locations

Locations (1)

University Hospital of Bonn; 🇩🇪 Bonn, Northrhine Westfalia, Germany