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

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

Detailed Description
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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..

Official Title
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Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal With 4F-PCC

Conditions
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Anticoagulation, Anticoagulation Reversal

Intervention / Treatment
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* Drug: four factor prothrombin complex concentrate


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study of consecutive patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Based on starting international normalized ratio (INR) and target INR, the dose of four factor prothrombin complex concentrate will be calculated and infused. Coagulation factor levels will be assessed over 48-72 hours. | Drug: four factor prothrombin complex concentrate<br>* After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | assessment of change in vitamin K dependent coagulation factor levels after infusion of 4F-PCC | through 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | bleeding | 30 days | 
| adverse events | thrombosis | 30 days |