Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2022
  • participants needed
    50
  • sponsor
    Brigham and Women's Hospital
Updated on 14 May 2021

Summary

Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).

Description

Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..

Details
Condition Anticoagulation, Anticoagulation Reversal, anticoagulation therapy
Treatment four factor prothrombin complex concentrate
Clinical Study IdentifierNCT03473132
SponsorBrigham and Women's Hospital
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria

recent thrombotic event
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