A Prospective Study on Warfarin Management Post Heart Valve Replacement or Heart Valve Repair Surgery

Phase 4

Withdrawn

• Conditions: Post Mechanical Heart Valve Surgery; Warfarin Management in post mechanical heart valve surgery patients.; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12613000818730
• Lead Sponsor: Flinders Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-24
• Last Update Posted: 29 March 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Male or Female, > 18 years old
-Undergoing elective mechanical heart valve surgery
-Able to provide written informed consent, and follow-up by Hospital-at-Home

Exclusion Criteria

-Unable to provide written informed consent
-Current atrial fibrillation
-Advanced malignancy
-Fluctuating thyroid state
-Requires emergent/salvage surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to achieve an initial stable therapeutic INR in post mechanical aortic and mitral valve replacement surgery patients is defined as the first measured INR within the range of 2-2.5 for mechanical aortic valves and 3-3.5 for mechanical mitral valves; where the previous/subsequent two INRs vary by no more than 0.5. INR tests will be taken by venapuncture or by point-of-care CoaguChek 'Registered Trademark' INR monitor at a maximum of daily, or minimum of two weekly as needed per recommended guidelines. INR results will be collected either directly from pathology laboratory or from patient diary up to a 12 week post-surgery timeline. [To be determined by study.]