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

ConditionVon Willebrand Disease (VWD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Optimized management

    Procedure/Surgery

    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

    Procedure/Surgery

    Standard of care management

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Optimized managementExperimental treatment 1 intervention
Group B: Standard of care managementOther 1 intervention

Trial outcomes

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

Time frame
Until the visit 7 (72 months ±2months)

Secondary outcomes

1

Number of GI bleeding and severe epistaxis recurrence during follow-up

Time frame
Until the visit 7 (72 months ±2months)
2

Number of days of hospitalization for GI bleeding or severe epistaxis recurrence during follow-up

Time frame
Until the visit 7 (72 months ±2months)
3

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)
4

Change in haemoglobin and serum ferritin levels from inclusion to 3-years

Time frame
from inclusion to 3-years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Source ClinicalTrials.gov
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