Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support (PHAM)

University Hospital, Lille

Status and phase: Terminated; Phase 3

Conditions: Heart Failure

Treatments: Drug: Prophylactic treatment with Wilfactin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02488525

PHRC-14-0469 (Other Identifier)

2015_06

2015-001231-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Wilfactin

Experimental group

Description:

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

Treatment:

Drug: Prophylactic treatment with Wilfactin

Control

No Intervention group

Description:

The control group will receive all treatments according to standard of care which does not include prophylactic administration of Wilfactin®