Reinforcement Learning for Warfarin Dosing

Clotting Disorder Clinical Trial

Official title:

Randomized Trial of Reinforcement Learning for the Dosing of Warfarin

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03962400
• Other study ID #: KDP002
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Clotting Disorder
• Hemostatic Disorders

Intervention

Procedure:
• Reinforcement Learning
New computer based procedure for determining dose using a decision support tool
• Heath Care Provider
Warfarin dose will be determined by a qualified health care provider

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent in Range	Percent of INR measurements within the Target Range	6 months
Secondary	Adverse Events	Composite of all adverse events attributed to warfarin	6 Months