N/A
N=104
Multidisciplinary Evaluation of Patients With Hemophilia
Haemophilia
Bottom Line
View on ClinicalTrials.gov: NCT02198430 ↗Enrolled (actual)
104
Serious AEs
—
Results posted
Oct 2016
Primary outcome: Primary: Assess the Joint Damage — 0.36; 0 points
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- Male
- Sponsor
- Universidad de Murcia
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Joint Damage |
0.36; 0 | — |
| PRIMARY Assess the Perception of Quality of Life |
38.32; 37.55 | — |
| SECONDARY Assessment of Clinical Patient Variables |
92.5; 0 | — |
| SECONDARY Measure of Weight |
41.59; 39.36 | — |
Summary
Multidisciplinary assessment of the physical, functional and psychosocial alterations in patients with hemophilia around the country. The aims of this study are:
* Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis.
* Descriptive study of the alterations of periarticular muscle strength as a result of acute processes or the development of chronic articular sequelae.
* Descriptive study of biomechanical changes in lower limb joints and their impact on gait in patients with hemophilia.
* Descriptive study of the joint space, regarding hemarthrosis and synovitis, intraarticular by ultrasonography.
* Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.
Eligibility Criteria
Inclusion Criteria
- Patients with hemophilia A and B.
- Patients of all ages (pediatric, adolescents, youth and adults).
- With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint loading.
- Patients with or without inhibitors.
Exclusion Criteria
- Patients without prior walking capacity.
- Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
- Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
Data sourced from ClinicalTrials.gov (NCT02198430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.