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NCT Number: NCT06651255

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

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.

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Key information

Conditions

Von Willebrand Disease (VWD) Angiodysplasia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Epistaxis Gastrointestinal Diseases Gastrointestinal Hemorrhage Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases von Willebrand Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Lille, Lille, Nord, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optimized management

Procedure

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

Standard of care management

Primary outcomes

  1. cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up

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

    • 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

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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Caillierez

CONTACT

[email protected]

0033320444145

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: WILL MANAGE

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Oct 21, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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