Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-20

Study Completion Date

2018-09-05

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.

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Prophylactic treatment with Wilfactin

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Prophylactic treatment with VWF factor concentrate

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No