RecruitingNot ApplicableNCT06651255

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

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


Sponsor

University Hospital, Lille

Enrollment

66 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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

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Interventions

PROCEDUREOptimized 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

PROCEDUREStandard of care management

Standard of care management


Locations(17)

CHU Lille

Lille, Nord, France

CHU Tours

Tours, Tours, France

CHU Amiens

Amiens, France

CHRU Brest

Brest, France

Hôpital cardiologique Louis Pradel

Bron, France

CHU Caen

Caen, France

CH Chambery

Chambéry, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHU Dijon

Dijon, France

AP-HP Hôpital Kremlin Bicetre

Le Kremlin-Bicêtre, France

AP-HM Hôpital Timone

Marseille, France

CHU Montpellier

Montpellier, France

CHU Nantes

Nantes, France

CHU Rennes

Rennes, France

CHU Rouen

Rouen, France

CHU Strasbourg

Strasbourg, France

CHU Toulouse

Toulouse, France

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NCT06651255


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