Algorithm-based Management to Reduce the Recurrence of GI Bleeding and Severe Epistaxis in Von Willebrand Disease
WILL-MANAGE
2 other identifiers
interventional
66
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2024
CompletedFirst Posted
Study publicly available on registry
October 21, 2024
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 6, 2034
March 13, 2025
March 1, 2025
9 years
October 18, 2024
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up
\- GI bleeding is defined as: Any hematemesis or melena Or hematochezia with at least a 2g/dL drop in hemoglobin Or occult bleeding: iron deficiency anemia with at least a 2g/dL drop in hemoglobin \- Severe epistaxis is defined as: A nose bleed requiring red blood cells transfusion or treatment with VWF concentrates
Until the visit 7 (72 months ±2months)
Secondary Outcomes (6)
Number of GI bleeding and severe epistaxis recurrence during follow-up
Until the visit 7 (72 months ±2months)
Number of days of hospitalization for GI bleeding or severe epistaxis recurrence during follow-up
Until the visit 7 (72 months ±2months)
Number of transfused red blood cells units, the total amount of iron supplementation (mg) and number of units of VWF concentrates administred (IU/kg) during follow-up
Until the visit 7 (72 months ±2months)
Change in haemoglobin and serum ferritin levels from inclusion to 3-years
from inclusion to 3-years
Change in bleeding score (ISTH BAT) from inclusion to 3-years. The bleeding score will be calculated for the 3-year period before the evaluation.
from inclusion to 3-years
- +1 more secondary outcomes
Study Arms (2)
Optimized management
EXPERIMENTALsystematic 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
Standard of care management
OTHERStandard of care management
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
CHU Lille
Lille, Nord, 59000, France
CHU Tours
Tours, Tours, 37000, France
CHU Amiens
Amiens, 80000, France
CHRU Brest
Brest, 29200, France
Hôpital cardiologique Louis Pradel
Bron, 69500, France
CHU Caen
Caen, 14000, France
CH Chambery
Chambéry, 73000, France
CHU Clermont-Ferrand
Clermont-Ferrand, 63000, France
CHU Dijon
Dijon, 21000, France
AP-HP Hôpital Kremlin Bicetre
Le Kremlin-Bicêtre, 94270, France
AP-HM Hôpital Timone
Marseille, 13005, France
CHU Montpellier
Montpellier, 34000, France
CHU Nantes
Nantes, 44000, France
CHU Rennes
Rennes, 35000, France
CHU Rouen
Rouen, 76000, France
CHU Strasbourg
Strasbourg, 67000, France
CHU Toulouse
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie Susen, MD, Professor
Lille University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2024
First Posted
October 21, 2024
Study Start
April 1, 2025
Primary Completion (Estimated)
April 1, 2034
Study Completion (Estimated)
December 6, 2034
Last Updated
March 13, 2025
Record last verified: 2025-03