Reinforcement Learning for Warfarin Dosing

Sponsor

University of Louisville (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03962400

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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.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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percent in Range [6 months]
Percent of INR measurements within the Target Range

Secondary Outcome Measures

Adverse Events [6 Months]
Composite of all adverse events attributed to warfarin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Louisville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adam Edward Gaweda, Associate Professor, University of Louisville

ClinicalTrials.gov Identifier:

NCT03962400

Other Study ID Numbers:

KDP002

First Posted:

May 24, 2019

Last Update Posted:

Mar 4, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Adam Edward Gaweda, Associate Professor, University of Louisville

warfarin

Additional relevant MeSH terms:

Hemostatic Disorders

Blood Coagulation Disorders

Study Results

No Results Posted as of Mar 4, 2022