Recruiting

Warfarin with 4F-PCC

Sponsor:

Brigham and Women's Hospital

Code:

NCT03473132

Conditions

Anticoagulation

Anticoagulation Reversal

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

four factor prothrombin complex concentrate

Study Details

Brief summary:

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

Conditions

Anticoagulation

Anticoagulation Reversal

Study ID

NCT03473132

Start date

Mar 15, 2018

Status verified date

Apr, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria:

  • recent thrombotic event

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 [ Time Frame: through 48 hours ]

Central Contacts and Locations

Central contacts

Jean M Connors, MD

617-525-9337jconnors@bwh.harvard.edu

Revital Freedman, PhD

617-525-9337rfreedman5@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kate Jolley, BA

617-525-9337kljolley@bwh.harvard.edu

Revital Freedman, PhD

617-525-9337rfreedman5@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

May 5, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2021-05-05.