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

What this Trial Is About

Researchers are evaluating an algorithm-based multidisciplinary management approach compared to standard care to reduce the recurrence of gastrointestinal (GI) bleeding or severe nosebleeds (epistaxis) in adults with von Willebrand Disease (VWD). This prospective, multicenter, randomized trial aims to investigate whether this new management strategy can lower the incidence of bleeding episodes over time. Participants are assigned to one of two groups: an optimized management group or a standard care group. The optimized management includes systematic gastrointestinal and nasal endoscopic examinations, local endoscopic treatments when needed, stepwise dose escalation of von Willebrand factor (VWF) concentrate, and the use of antiangiogenic drugs for patients with severe GI angiodysplasia-related bleeding. The standard care group receives usual management without this structured approach. During the study, participants will be followed for up to 72 months with regular visits to monitor bleeding recurrence, hospitalizations, and treatments received. Researchers will assess the number of bleeding episodes, hospital days, blood transfusions, iron supplementation, and VWF concentrate usage. They will also measure changes in hemoglobin, serum ferritin, bleeding scores, and quality of life using a validated questionnaire. This comprehensive monitoring aims to provide detailed information on treatment impact and patient well-being throughout the trial.

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