Algorithm-based Management to Reduce the Recurrence of GI Bleeding and Severe Epistaxis in Von Wi… (NCT06651255) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Algorithm-based Management to Reduce the Recurrence of GI Bleeding and Severe Epistaxis in Von Willebrand Disease
France66 participantsStarted 2025-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* Acquired von Willebrand Disease
* Presence of an inhibitor to VWF or a contra indication to VWF concentrates
* Contra-indication to videocapsule endoscopy
* Refusal of the procedures part of the study
* Pregnant women or breastfeeding
* Short-life expectancy
* Liver cirrhosis Child-Pugh C or diagnosed portal hypertension
* Cancer currently undergoing chemotherapy
* Inability to provide informed consent
* Patient under justice protection
What they're measuring
1
cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up
Timeframe: Until the visit 7 (72 months ±2months)