Sonography and Haemophilia

NCT04550988 | Unknown

• 1 other identifier: POD10816
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Sonography; Haemophilia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

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

Other: feasibility study

Interventions

feasibility study OTHER

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.

Adult patients with severe haemophilia A or B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead
• Swedish Orphan Biovitrum: collaborator

Study Sites (1)

University Hospital of Bonn

Bonn, Northrhine Westfalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Interventions

Feasibility Studies

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andreas Strauß, PD Dr.

  Medicine of the University of Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Strauß, PD Dr.

CONTACT

004922828714176; andreas.strauss@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in orthopedics and trauma surgery

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 16, 2020
• Study Start: February 8, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)