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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03473132
Other study ID # 2017P001254
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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