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

Anticoagulation Clinical Trial

— KVAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03473132
• Other study ID #: 2017P001254
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2021
• Source: Brigham and Women's Hospital
• Contact: Jean M Connors, MD
• Phone: 617-525-9337
• Email: jconnors[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria:

• recent thrombotic event

Related Conditions & MeSH terms

• Anticoagulation
• Anticoagulation Reversal

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	bleeding	30 days
Secondary	adverse events	thrombosis	30 days