Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin
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|ClinicalTrials.gov Identifier: NCT02267408|
Recruitment Status : Terminated (Terminated by sponsor)
First Posted : October 17, 2014
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypoprothrombinemia||Other: Warfarin adjustment using the Fearon algorithm Other: Warfarin adjustment using standard dosing||Phase 1 Phase 2|
Patients with very variable INRs resulting in a low proportion of time in therapeutic range (TTR) have a higher risk of both bleeding complications and thromboembolic events. A good TTR is generally considered to be over 60% and "excellent TTR" is above 72% of time in range. The investigators will recruit patients with a TTR below 50%.
The Fearon algorithm provides a more thorough understanding of the individual responses to changes in warfarin dose and with a personalized nomogram for dose adjustments and timing of laboratory tests the investigators have an opportunity to improve the TTR and on a larger scale to reduce clinically important adverse events. Before embarking on a large randomized trial with this revised Fearon algorithm-derived nomogram this pilot study with a randomized, open-label design will be performed to demonstrate proof of principle.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Dosing of warfarin according to the Fearon algorithm or routine during 6 months for patients with unstable INRs|
|Masking:||None (Open Label)|
|Official Title:||A Single-site, Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Patients With Unstable Warfarin Effect.|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 3, 2017|
Experimental: Fearon algorithm dosing
Warfarin adjustment using the Fearon algorithm
Other: Warfarin adjustment using the Fearon algorithm
All available historical data will be used to calculate with the Fearon algorithm the individual sensitivity to warfarin and to dose changes as well as lag time until a dose adjustment reaches full effect. Based on this a personal dosing nomogram will be developed and provided to the investigator and to the patients. This nomogram will be used during 6 month but override is possible if the investigator feels that the suggestion from the nomogram is unsafe.
Active Comparator: Standard dosing
Warfarin adjustment using standard dosing
Other: Warfarin adjustment using standard dosing
Patients will receive warfarin dosing instructions from a trained nurse using fixed nomograms and computer-based dosing suggestion.
- Improvement in TTR [ Time Frame: 6 months ]The percent units of TTR during the 6 months will be compared with the percent units TTR in the previous year
- Proportion of patients with improvement in TTR [ Time Frame: 6 months ]Proportion of included patients with TTR improvement of more than 5 percent units
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267408
|Thrombosis Service, HHS-General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Sam Schulman, MD, PhD||McMaster University|