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

Last updated: April 30, 2021
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Blood Clots

Treatment

N/A

Clinical Study ID

NCT03473132
2017P001254
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion

Exclusion Criteria:

  • recent thrombotic event

Study Design

Total Participants: 50
Study Start date:
March 15, 2018
Estimated Completion Date:
March 31, 2022

Study 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..

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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