Reinforcement Learning for Warfarin Dosing

Study Overview
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Brief Summary
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This is a clinical study designed to test the hypothesis that a computer model for dosing warfarin is superior to current clinical practice. Subjects will be randomized to two groups based on how warfarin dose is determined and followed for 6 months. The primary outcome is the percent of the time that the INR is maintained in the effective range.

Detailed Description
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This will be a single-center, open-label, randomized prospective study. Primary outcome will be percent of time within a specific INR range. Subjects will be randomized to to control and treatment groups and stratified 1:1 based on sex. The control group will have warfarin doses adjusted by experts in the treatment of patients with warfarin. The treatment group will have warfarin doses determined using a clinical support tool based on reinforcement learning. Based on simulations of the experimental design with an expectation that the percent of INR values within the target range increase by 20%, 70 subjects per group are required for statistical significance. Based on an attrition rate of 15%, the investigators will enroll 80 subjects per group. Statistical analysis will compare the percent of patients within the target INR range between groups as the primary outcome with number of adverse events between groups as the safetly outcome.

Official Title
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Randomized Trial of Reinforcement Learning for the Dosing of Warfarin

Conditions
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Clotting Disorder

Intervention / Treatment
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* Procedure: Reinforcement Learning
* Procedure: Heath Care Provider


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving anticoagulation treatment with warfarin. Exclusion Criteria: Pregnancy. History of hemorrhagic cerebrovascular incident. Acquired or inherited hemophilia. Thrombocytopenia (<100,000 platelets per mm3) on 2 occasions separated by 2 days. Anemia with hemoglobin concentration < 10 g/dL. Active cancer excluding non-melanoma skin cancers. Active liver disease as documented by prolonged baseline INR ≥ 1.6. Uncontrolled hypertension with 2 readings >180/110. Recent (< 2 weeks) neurosurgical procedure. Enrollment in hospice program for any diagnosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial of 2 groups. Subjects in the Control group will receive warfarin with dose adjustment guided by standard protocol. Subjects in the Treatment group will receive warfarin with dose adjustment guided by personalized protocol.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Subjects will have warfarin dose determined in the usual fashion by a health care provider. | Procedure: Heath Care Provider<br>* Warfarin dose will be determined by a qualified health care provider<br>|
| Experimental: Treatment<br>Subjects will have warfarin dose determined using a reinforcement learning computer model. | Procedure: Reinforcement Learning<br>* New computer based procedure for determining dose using a decision support tool<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent in Range | Percent of INR measurements within the Target Range | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Composite of all adverse events attributed to warfarin | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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warfarin