Reinforcement Learning for Warfarin Dosing

NCT ID: NCT03962400

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Clotting Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Subjects will have warfarin dose determined in the usual fashion by a health care provider.

Group Type: ACTIVE_COMPARATOR

Heath Care Provider

Intervention Type: PROCEDURE

Warfarin dose will be determined by a qualified health care provider

Treatment

Subjects will have warfarin dose determined using a reinforcement learning computer model.

Group Type: EXPERIMENTAL

Reinforcement Learning

Intervention Type: PROCEDURE

New computer based procedure for determining dose using a decision support tool

Interventions

Reinforcement Learning

New computer based procedure for determining dose using a decision support tool

Intervention Type: PROCEDURE

Heath Care Provider

Warfarin dose will be determined by a qualified health care provider

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Adam Edward Gaweda

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KDP002

Identifier Type: -

Identifier Source: org_study_id