Reinforcement Learning for Warfarin Dosing

Phase 4

Withdrawn

• Conditions: Clotting Disorder
• Interventions: Procedure: Heath Care Provider; Procedure: Reinforcement Learning

• Registration Number: NCT03962400
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Study Start: 2022-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Heath Care Provider	Subjects will have warfarin dose determined in the usual fashion by a health care provider.
Treatment	Reinforcement Learning	Subjects will have warfarin dose determined using a reinforcement learning computer model.

Primary Outcome Measures

Name	Time	Method
Percent in Range	6 months	Percent of INR measurements within the Target Range

Secondary Outcome Measures

Name	Time	Method
Adverse Events	6 Months	Composite of all adverse events attributed to warfarin