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

University Hospital, Lille

Status: Not yet enrolling

Conditions: Von Willebrand Disease (VWD)

Treatments: Procedure: Optimized management; Procedure: Standard of care management

Study type: Interventional

Funder types: Other

Identifiers

NCT06651255

2022_0508

2023-A01508-37 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Optimized management

Experimental group

Description:

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

Treatment:

Procedure: Optimized management

Standard of care management

Other group

Description:

Standard of care management

Treatment:

Procedure: Standard of care management