Sonography and Haemophilia

May 18, 2022 updated by: PD Dr. Andreas Strauß, University Hospital, Bonn

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:

  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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Northrhine Westfalia
      • Bonn, Northrhine Westfalia, Germany, 53127
        • Recruiting
        • University Hospital of Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

5 min
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.

5 min
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.

5min
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.

5 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2021

Primary Completion (ANTICIPATED)

July 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (ACTUAL)

September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The publication of anonymous patient data is not allowed by informed consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Haemophilia

Clinical Trials on feasibility study

3
Subscribe