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Reinforcement Learning for Warfarin Dosing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03962400
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Information provided by (Responsible Party):
Adam Edward Gaweda, University of Louisville

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Clotting Disorder Procedure: Reinforcement Learning Procedure: Heath Care Provider Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description: Subjects will not be informed of group designation
Primary Purpose: Treatment
Official Title: Randomized Trial of Reinforcement Learning for the Dosing of Warfarin
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Control
Subjects will have warfarin dose determined in the usual fashion by a health care provider.
Procedure: Heath Care Provider
Warfarin dose will be determined by a qualified health care provider

Experimental: Treatment
Subjects will have warfarin dose determined using a reinforcement learning computer model.
Procedure: Reinforcement Learning
New computer based procedure for determining dose using a decision support tool

Primary Outcome Measures :
  1. Percent in Range [ Time Frame: 6 months ]
    Percent of INR measurements within the Target Range

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 6 Months ]
    Composite of all adverse events attributed to warfarin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Adam Edward Gaweda, Associate Professor, University of Louisville Identifier: NCT03962400     History of Changes
Other Study ID Numbers: KDP002
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Adam Edward Gaweda, University of Louisville:
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders