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

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

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

Study Overview

• Status: Recruiting
• Conditions: Anticoagulation; Anticoagulation Reversal
• Intervention / Treatment: Drug: four factor prothrombin complex concentrate

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jean M Connors, MD; Phone Number: 617-525-9337; Email: jconnors@bwh.harvard.edu
• Study Contact Backup: Name: Revital Freedman, PhD; Phone Number: 617-525-9337; Email: rfreedman5@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Revital Freedman, PhD; Phone Number: 617-525-9337; Email: rfreedman5@bwh.harvard.edu
      • Contact: Kate Jolley, BA; Phone Number: 617-525-9337; Email: kljolley@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria:

• recent thrombotic event

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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; After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: CSL Behring
• Investigators: Principal Investigator: Jean M Connors, MD, Brigham and Women';s Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: 2017P001254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No