Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

Phase 3

Terminated

• Conditions: Heart Failure
• Interventions: Drug: Prophylactic treatment with Wilfactin

• Registration Number: NCT02488525
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Study Start: 2016-01-20
• Primary Completion: 2018-09-05
• Study Completion: 2018-09-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wilfactin	Prophylactic treatment with Wilfactin	Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with clinically significant bleeding within 3 months after implantation	3 months	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

Trial Locations

Locations (1)

CHRU,; 🇫🇷 Lille, France