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

Phase 4

• Conditions: Anticoagulation; Anticoagulation Reversal
• Interventions: Drug: four factor prothrombin complex concentrate

• Registration Number: NCT03473132
• Lead Sponsor: Brigham and Women's Hospital

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-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 Timeline

• Study First Submitted: 2018-02-07
• Study Start: 2018-03-15
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-05
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria

• recent thrombotic event

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	four factor prothrombin complex concentrate	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.

Primary Outcome Measures

Name	Time	Method
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	through 48 hours	assessment of change in vitamin K dependent coagulation factor levels after infusion of 4F-PCC

Secondary Outcome Measures

Name	Time	Method
Adverse events	30 days	bleeding
adverse events	30 days	thrombosis

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States