NCT03473132

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

3.8 years

First QC Date

February 7, 2018

Last Update Submit

April 30, 2021

Conditions

AnticoagulationAnticoagulation Reversal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Adverse events

    30 days

  • adverse events

    30 days

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

four factor prothrombin complex concentrateDRUG

After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.

Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

You may not qualify if:

  • recent thrombotic event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

  • Jean M Connors, MD

    Brigham and Women';s Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean M Connors, MD

CONTACT

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

Revital Freedman, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot study of consecutive patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Hemostatic and Antithrombotic Stewardship Program

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 22, 2018

Study Start

March 15, 2018

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

May 5, 2021

Record last verified: 2021-04

Locations

US(1)