UnknownPhase 4

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

United States50 participantsStarted 2018-03-15

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion Criteria: * LVAD on warfarin requiring temporary interruption of anticoagulation for procedures Exclusion Criteria: * recent thrombotic event

What they're measuring

plasma concentration of factors II,VII, IX, X, proteins S and C every 6 hours for 48 hours after treatment with 4F-PCC and correlation with international normalized ratio

Timeframe: through 48 hours

Trial details

NCT IDNCT03473132

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Contact for this trial

Jean M Connors, MD

617-525-9337 jconnors@bwh.harvard.edu

View on ClinicalTrials.gov More Anticoagulation trials