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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001231-20 | EudraCT Number | ||
| PHRC-14-0469 | Other Identifier | Ministry of health, France |
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| Name | Class |
|---|---|
| Laboratoire français de Fractionnement et de Biotechnologies | INDUSTRY |
| Ministry of Health, France | OTHER_GOV |
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Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment.
This time point was chosen because the bleeding events are maximal within the first 3 months after implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wilfactin | Experimental | Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care. |
|
| Control | No Intervention | The control group will receive all treatments according to standard of care which does not include prophylactic administration of Wilfactin® |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic treatment with Wilfactin | Drug | Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with clinically significant bleeding within 3 months after implantation | A clinically significant bleeding event is defined as internal or external bleeding leading to death or prolonged hospitalization or requiring re-hospitalization, surgery or transfusion of at least 3 units of packed red blood cells or hemoglobin drop> 3g/dL and/or refractory to conventional approach | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susen Sophie, MD, PhD | University Hospital, Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU, | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12878741 | Background | Vincentelli A, Susen S, Le Tourneau T, Six I, Fabre O, Juthier F, Bauters A, Decoene C, Goudemand J, Prat A, Jude B. Acquired von Willebrand syndrome in aortic stenosis. N Engl J Med. 2003 Jul 24;349(4):343-9. doi: 10.1056/NEJMoa022831. | |
| 25670067 | Background | Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |