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Clinical Trial Summary

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


Clinical Trial 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.. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03473132
Study type Interventional
Source Brigham and Women's Hospital
Contact Jean M Connors, MD
Phone 617-525-9337
Email jconnors@bwh.harvard.edu
Status Recruiting
Phase Phase 4
Start date March 15, 2018
Completion date March 31, 2022

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