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

Launched by UNIVERSITY HOSPITAL, LILLE · Oct 18, 2024

Keywords

ClinConnect Summary

The WILL MANAGE trial is studying a new approach to help people with von Willebrand Disease (VWD) who have had serious bleeding problems, such as gastrointestinal (GI) bleeding or severe nosebleeds (epistaxis). This trial compares a specialized management plan that uses a team of healthcare providers to standard treatment, aiming to reduce the chances of these bleeding events happening again.

To take part in this study, participants need to be adults over 18 years old with a specific type of VWD and a history of significant GI bleeding or severe nosebleeds that required medical treatment. The trial is currently not recruiting participants, but once it begins, those who qualify will receive either the new management strategy or standard care. It's important to know that some individuals, such as those with certain health conditions or who are pregnant, won’t be able to join the study. Overall, this trial hopes to find a better way to manage bleeding in patients with VWD, improving their quality of life and health outcomes.

Gender

ALL

Eligibility criteria

• 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