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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03473132

Acronym

KVAD

Enrollment

Registered

2018-03-22

Start date

2018-03-15

Completion date

2022-03-31

Last updated

2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation, Anticoagulation Reversal

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..

Interventions

DRUGfour 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Pilot study of consecutive patients.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion criteria

* recent thrombotic event

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adverse events	30 days	bleeding
adverse events	30 days	thrombosis

Countries

United States

Contacts

Primary ContactJean M Connors, MD

jconnors@bwh.harvard.edu617-525-9337

Backup ContactRevital Freedman, PhD

rfreedman5@bwh.harvard.edu617-525-9337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026