Algorithm-based Management to Reduce the Recurrence of GI Bleeding and Severe Epistaxis in Von Willebrand Disease
NCT ID: NCT06651255
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2025-04-30
2034-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Optimized 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
Optimized 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
Standard of care management
Standard of care management
Standard of care management
Standard of care management
Interventions
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Optimized 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
Standard of care management
Standard of care management
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Sophie Susen, MD, Professor
Role: PRINCIPAL_INVESTIGATOR
Lille University Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A01508-37
Identifier Type: OTHER
Identifier Source: secondary_id
2022_0508
Identifier Type: -
Identifier Source: org_study_id
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