Идёт набор NCT06651255

Algorithm-based Management to Reduce the Recurrence of GI Bleeding and Severe Epistaxis in Von Willebrand Disease

Без фазы С лечением Von Willebrand Disease (VWD)

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: Optimized management, Standard of care management.
Кому может быть актуально: Состояния в реестре: Von Willebrand Disease (VWD). Базовые параметры: от 18 лет · 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: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Algorithm-based Management to Reduce the Recurrence of Gastrointestinal Bleeding and Severe Epistaxis in Von Willebrand Disease: WILL-MANAGE Trial

Обзор

WILL MANAGE is a prospective multicenter controlled open label randomized trial comparing an algorithm-based multidisciplinary management to a standard of care to reduce the incidence of bleeding (GI bleeding or severe epistaxis) recurrence in von Willebrand disease.

Вмешательства

Процедура Optimized management
systematic gastrointestinal and nasal endoscopic exploration, local endoscopic treatment whenever applicable,prophylaxis with stepwise dose escalation of VWF concentrate and use of antiangiogenic drugs in patients with severe GI angiodysplasia-related bleeding
Процедура Standard of care management
Standard of care management

Первичные конечные точки

cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up [Срок оценки: Until the visit 7 (72 months ±2months)]

Вторичные конечные точки (6)

Number of GI bleeding and severe epistaxis recurrence during follow-up [Срок оценки: Until the visit 7 (72 months ±2months)]
Number of days of hospitalization for GI bleeding or severe epistaxis recurrence during follow-up [Срок оценки: Until the visit 7 (72 months ±2months)]
Number of transfused red blood cells units, the total amount of iron supplementation (mg) and number of units of VWF concentrates administred (IU/kg) during follow-up [Срок оценки: Until the visit 7 (72 months ±2months)]
Change in haemoglobin and serum ferritin levels from inclusion to 3-years [Срок оценки: from inclusion to 3-years]
Change in bleeding score (ISTH BAT) from inclusion to 3-years. The bleeding score will be calculated for the 3-year period before the evaluation. [Срок оценки: from inclusion to 3-years]
Change in quality of life assessed by a standardized questionnaire validated for VWD (WISH-QoL scores) from inclusion to 3 years [Срок оценки: from inclusion to 3-years]

Критерии участия

Критерии включения

Males and females adults aged > 18 years
With a constitutional von Willebrand Disease (according to the phenotypic criteria of the French Reference Center of von Willebrand Disease)
With a GI bleeding \[either overt (any hematemesis, any melena or hematochezia with at least a 2g/dL drop in hemoglobin) or occult (iron deficiency anemia with at least 2g/dL drop in hemoglobin)\] with the presence of angiodysplasia or a negative finding on digestive conventional endoscopy OR with a severe epistaxis (requiring red blood cells transfusion or treatment with VWF concentrates)
Be affiliated to a social security scheme
Written informed consent obtained