Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

Study Overview
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Brief Summary
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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.

Detailed Description
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This time point was chosen because the bleeding events are maximal within the first 3 months after implantation. Adult patients > 18 years who need a CF-LVAD due to advanced heart failure. Functional To determine the potential indication of Wilfactin® in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis.

Official Title
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Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Prophylactic treatment with Wilfactin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients > 18 years who need a CF-LVAD due to advanced heart failure. Functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >180 sec and or VWF:Act/VWF:Ag≤ 0.7) Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated) Exclusion Criteria: Treatment with Wilfactin® within the last seven days Previous adverse reaction to Wilfactin® Absence of functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >250 sec and or VWF:Act/VWF:Ag<0.7) Patient with a known thrombophilia Patient with a known severe bleeding disorder Patient refusal or environment Minor patients Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wilfactin<br>Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care. | Drug: Prophylactic treatment with Wilfactin<br>* Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.<br>* Other names: Prophylactic treatment with VWF factor concentrate;|
| No Intervention: Control<br>The control group will receive all treatments according to standard of care which does not include prophylactic administration of Wilfactin® | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acquired Von Willebrand, Gastro-intestinal bleeding, LVAD