Status:

UNKNOWN

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

Lead Sponsor:

Brigham and Women's Hospital

Collaborating Sponsors:

CSL Behring

Conditions:

Anticoagulation

Anticoagulation Reversal

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

Brief Summary

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

Detailed 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...

Eligibility Criteria

Inclusion

  • LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion

  • recent thrombotic event

Key Trial Info

Start Date :

March 15 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2022

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT03473132

Start Date

March 15 2018

End Date

March 31 2022

Last Update

May 5 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115