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Recruiting NCT06651255

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

No phase Interventional Von Willebrand Disease (VWD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optimized management, Standard of care management.
Who it may be relevant to
Registry conditions: Von Willebrand Disease (VWD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure 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
  • Procedure Standard of care management
    Standard of care management

Primary outcome measures

  • cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up [Time frame: Until the visit 7 (72 months ±2months)]
Secondary outcome measures (6)
  • Number of GI bleeding and severe epistaxis recurrence during follow-up [Time frame: Until the visit 7 (72 months ±2months)]
  • Number of days of hospitalization for GI bleeding or severe epistaxis recurrence during follow-up [Time frame: 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 [Time frame: Until the visit 7 (72 months ±2months)]
  • Change in haemoglobin and serum ferritin levels from inclusion to 3-years [Time frame: 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. [Time frame: from inclusion to 3-years]
  • Change in quality of life assessed by a standardized questionnaire validated for VWD (WISH-QoL scores) from inclusion to 3 years [Time frame: from inclusion to 3-years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 17 centers
  • CHU Lille — Lille
  • CHU Tours — Tours
  • CHU Amiens — Amiens
  • CHRU Brest — Brest
  • Hôpital cardiologique Louis Pradel — Bron
  • CHU Caen — Caen
  • CH Chambery — Chambéry
  • CHU Clermont-Ferrand — Clermont-Ferrand
  • … and 9 more centers

Identifiers

NCT: NCT06651255 · 2022_0508 · 2023-A01508-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗