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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01508-37 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized management | Experimental | 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 |
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| Standard of care management | Other | Standard of care management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Caillierez | Contact | 0033320444145 | DRC@chru-lille.Fr |
| Name | Affiliation | Role |
|---|---|---|
| Sophie Susen, MD, Professor | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lille | Not yet recruiting | Lille | Nord | 59000 | France |
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| Standard of care management | Procedure | Standard of care management |
|
| 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 |
| Change in quality of life assessed by a standardized questionnaire validated for VWD (WISH-QoL scores) from inclusion to 3 years | from inclusion to 3-years |
| CHU Tours | Not yet recruiting | Tours | Tours | 37000 | France |
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| CHU Amiens | Not yet recruiting | Amiens | 80000 | France |
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| CHRU Brest | Not yet recruiting | Brest | 29200 | France |
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| Hôpital cardiologique Louis Pradel | Not yet recruiting | Bron | 69500 | France |
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| CHU Caen | Not yet recruiting | Caen | 14000 | France |
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| CH Chambery | Not yet recruiting | Chambéry | 73000 | France |
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| CHU Clermont-Ferrand | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| CHU Dijon | Not yet recruiting | Dijon | 21000 | France |
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| AP-HP Hôpital Kremlin Bicetre | Not yet recruiting | Le Kremlin-Bicêtre | 94270 | France |
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| AP-HM Hôpital Timone | Not yet recruiting | Marseille | 13005 | France |
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| CHU Montpellier | Recruiting | Montpellier | 34000 | France |
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| CHU Nantes | Not yet recruiting | Nantes | 44000 | France |
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| CHU Rennes | Not yet recruiting | Rennes | 35000 | France |
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| CHU Rouen | Not yet recruiting | Rouen | 76000 | France |
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| CHU Strasbourg | Not yet recruiting | Strasbourg | 67000 | France |
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| CHU Toulouse | Not yet recruiting | Toulouse | 31000 | France |
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| ID | Term |
|---|---|
| D014842 | von Willebrand Diseases |
| D006471 | Gastrointestinal Hemorrhage |
| D016888 | Angiodysplasia |
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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