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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
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
Standard of care management
CHU Lille
Lille, Nord, France
CHU Tours
Tours, Tours, France
CHU Amiens
Amiens, France
cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up
\- GI bleeding is defined as: Any hematemesis or melena Or hematochezia with at least a 2g/dL drop in hemoglobin Or occult bleeding: iron deficiency anemia with at least a 2g/dL drop in hemoglobin \- Severe epistaxis is defined as: A nose bleed requiring red blood cells transfusion or treatment with VWF concentrates
Time frame: Until the visit 7 (72 months ±2months)
Number of GI bleeding and severe epistaxis recurrence during follow-up
Time frame: Until the visit 7 (72 months ±2months)
Number of days of hospitalization for GI bleeding or severe epistaxis recurrence during follow-up
Time frame: 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
Time frame: Until the visit 7 (72 months ±2months)
Change in haemoglobin and serum ferritin levels from inclusion to 3-years
Time frame: 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.
Time frame: 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
Time frame: from inclusion to 3-years
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Caen, France
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Chambéry, France
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...and 7 more locations