Status:
COMPLETED
Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy
Lead Sponsor:
James A. Haley Veterans Administration Hospital
Conditions:
Coagulation Delay
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Warfarin is used as an anti-coagulant in patients at risk of developing thrombosis. It has a narrow therapeutic index necessitating close monitoring of International Normalized Ratio (INR)...
Detailed Description
See above.
Eligibility Criteria
Inclusion
- Be eighteen years of age and older
- Have a long-term indication for warfarin (will need to be on warfarin for 6 months or longer)
- Be a new patient on warfarin therapy, or a patient previously on warfarin therapy who has been taken off therapy for more than 2 weeks and needs to be titrated again
- Anticipate receiving medical care at the study site for the duration of the study
- Have transportation to and from the JAHVA
- Have read and signed the Informed Consent document after the study has been fully explained and has had all questions answered
Exclusion
- Have liver or kidney failure
- Are on hemodialysis or peritoneal dialysis
- Are pregnant or planning to become pregnant
- Have Alzheimer's disease, cognitive impairment, or visual impairment
- Are not compliant with medications
- Are participating in another study
- Have scheduled surgery or are planning to undergo major surgery
- Cannot be reached by telephone
- Take over-the-counter vitamin K supplementation except multivitamins
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT01474460
Start Date
September 1 2011
End Date
November 1 2015
Last Update
March 9 2017
Active Locations (1)
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1
James A. Haley VA Hospital
Tampa, Florida, United States, 33612