Prevalence of Synovitis in Patients With Haemophilia A

NCT06352216 | Recruiting

• 1 other identifier: Elo-Ger-2023-1642
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia A.

Conditions

Haemophilia A; Synovitis; Hemophilia Arthropathy; Sonography

Keywords

Synovitis; Haemophilia A; Prevalence

Outcome Measures

Primary Outcomes (1)

• Haemophilia early arthropathy detection with ultrasound (HEAD-US)

  HEAD-US protocol examines both elbow, knee and ankle joints sonographically and assesses the presence of synovitis or joint damage from 0-8 points per joint according to Martinoli et al. 2013. A "total score" of 0 to 48 points is achievable. A higher score means a worse joint status.

  20 minutes

Secondary Outcomes (3)

• The Hemophilia Joint Health Score version 2.1 (HJHS)

  45 minutes

• PROMIS-29 Questionaire

  10 minutes

• Haemophilia Activities List (HAL)

  10 minutes

Other Outcomes (1)

• Baseline Characteristics

  15 minutes

Study Arms (1)

Patients with Haemophilia A

Patients with severe and moderate Haemophilia A (FVIII \< 5 %, ≥ 18 years' old)

Diagnostic Test: Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US); Haemophilia joint health score (HJHS)

Interventions

Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US); Haemophilia joint health score (HJHS) DIAGNOSTIC_TEST

Each subject is examined for the presence of synovitis using the aforementioned diagnostics.

Patients with Haemophilia A

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 moderate (FVIII 1-5 %) or severe (FVIII \<1 %) haemophilia A.

You may qualify if:

• Participants (≥ 18 years old) suffering from moderate or severe haemophilia A, also with inhibitor or joint replacement
• Complete documentation of hemophilia severity, treatment history (past 12 months), and bleeding events (past 12 months), inhibitor status (at time of enrollment and in past medical history)
• Submitted written consent to participate in the study

You may not qualify if:

• Patients suffering from other bleeding disorders conflicting with the research question
• Patients in clinical studies with investigational drugs

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53113, Germany

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Synovitis

Interventions

Ultrasonography

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; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Andreas C Strauss, PD Dr. med.

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas C. Strauss, PD Dr. med.

CONTACT

+4922828714176; andreas.strauss@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 8, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)