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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03473132

Collaborator

CSL Behring (Industry)

Enrollment

Location

Arm

48.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation Anticoagulation Reversal	Drug: four factor prothrombin complex concentrate	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pilot study of consecutive patients.Pilot study of consecutive patients.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 15, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Adverse events [30 days]
bleeding
adverse events [30 days]
thrombosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria:

recent thrombotic event

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital
CSL Behring

Investigators

Principal Investigator: Jean M Connors, MD, Brigham and Women';s Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jean M Connors, Director, Hemostatic and Antithrombotic Stewardship Program, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT03473132

Other Study ID Numbers:

2017P001254

First Posted:

Mar 22, 2018

Last Update Posted:

May 5, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombin

Study Results

No Results Posted as of May 5, 2021