Embolization in Hereditary Coagulopathies
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: embolization with spherical microparticles embosphere.
- Кому может быть актуально
- Состояния в реестре: Hemophilia, Embolization, Hemarthrosis, Clotting Factor Deficiency. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бразилия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is a longitudinal, prospective study, which will include 30 subjects with hereditary coagulopathies, with arthropathy, chronic synovitis resulting from hemarthrosis of the elbows, knees and/or ankles followed up at the Centro de Hemofilia HCFMUSP, after approval by the ethics and research committee. They will undergo imaging tests (X-rays and Magnetic Resonance of knee, elbow, or ankle), physical, pain, quality of life and functional assessments (Hemophilia Joint Health Score, Functional Independence Score in Hemophilia, Perimeter, Test Timed up and Go, 30 second sit and stand test, Haemophilia - Adult - Quality of Life questionnaire (HAEM-A-QoL), Knee Injury and Osteoarthritis Outcome Score, EQ-5D, numerical rating scale for pain and embolization procedure (superselective embolization of target arteries with spherical microparticles Embosphere 100-300 micrometers (Biosphere Medical, Roissy, France), until partial vascular stasis and decharacterization of pathological synovial enhancement. These evaluations will be performed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.
Подробное описание
Longitudinal, prospective study, which will include 30 subjects with hereditary coagulopathies, with arthropathy, chronic synovitis resulting from hemarthrosis of the elbows, knees and/or ankles followed up at the Centro de Hemophilia do Hospital das Clinicas, Faculdade de Medicina da Universidade de São Paulo, i.e. HC-FMUSP), after approval by the ethics and research committee and registry at the clinical trials.
Patients will be evaluated by imaging (X-rays and Magnetic Resonance of the affected joint, i.e., knee, elbow, and/or ankle); physical and functional assessments (Hemophilia Joint Health Score, Functional Independence Score in Hemophilia, Perimeter of the affected joint(s), Test Timed up and Go, 30 second sit and stand test, Knee Injury and Osteoarthritis Outcome Score (KOOS); quality of life (Haemophilia - adult - quality of life questionnaires (HAEM-A-QoL), Knee Injury and Osteoarthritis Outcome Score (KOOS), EQ-5D; pain measured by numerical rating scale.
Volunteers will be submitted to embolization procedure (superselective embolization of target arteries with spherical microparticles embosphere 100-300 micrometers (Biosphere Medical, Roissy, France) of the affected joint(s), until partial vascular stasis and decharacterization of pathological synovial enhancement.
These evaluations will be performed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.
Вмешательства
- Устройство embolization with spherical microparticles embosphere
embolization of affected joints with spherical microparticles embosphere
Первичные конечные точки
- Reduction of synovium thickness by embolization [Срок оценки: 6 months]
Вторичные конечные точки (12)
- Reduction of synovitis by embolization [Срок оценки: 1, 3 12, 24, 36, 48 and 60 months]
- Inferior limb strength [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Inferior limb strength [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Balance and fall risk [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Quality of life of the patient [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Quality of life of the patient [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Quality of life of the patient [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Functional capacity [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Functional capacity [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Physical capacity [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Pain of the affected joint [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
- Pain of the affected joint [Срок оценки: 1, 3, 6, 12, 24, 36, 48, 60 months]
Критерии участия
Критерии включения
- Patients with hereditary coagulopathies with arthropathy (i.e., chronic synovitis due to hemarthrosis), with X-ray and MRI (documenting synovitis) followed up at the Hemophilia Center HC-FMUSP.
Критерии исключения
- Patients who do not complete the planned assessments
- Patients who do not accept to continue with the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Бразилия · 1 центр
- Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina d — São Paulo
Идентификаторы
NCT: NCT05629130 · 63452822.1.0000.0068