Reinforcement Learning for Warfarin Dosing

University of Louisville (UOFL)

Status and phase: Withdrawn; Phase 4

Conditions: Clotting Disorder

Treatments: Procedure: Reinforcement Learning; Procedure: Heath Care Provider

Study type: Interventional

Funder types: Other

Identifiers

NCT03962400

KDP002

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Procedure: Heath Care Provider

Treatment

Experimental group

Description:

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

Treatment:

Procedure: Reinforcement Learning