Reinforcement Learning for Warfarin Dosing | NCT03962400

Studies
Reinforcement Learning for Warfarin Dosing

NCT03962400

Sponsor

University of Louisville

Status

Withdrawn

Last Update Posted

Mar 4, 2022Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Clotting Disorder

Interventions

Reinforcement Learning
Heath Care Provider

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study did not receive anticipated funding and therefore never opened to enrollment. The study was never submitted to the IRB for approval since the funding failed.

Expanded Access Info

Start Date

Jan 1, 2022Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 21, 2019

First Submission Date that Met QC Criteria

May 23, 2019

First Posted Date

May 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2022

Last Update Posted Date

Mar 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adam Edward Gaweda, Associate Professor, University of LouisvillePrincipal Investigator

Lead Sponsor

University of LouisvilleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Subjects will have warfarin dose determined in the usual fashion by a health care provider.	Procedure: Heath Care Provider
Treatment	Experimental	Subjects will have warfarin dose determined using a reinforcement learning computer model.	Procedure: Reinforcement Learning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reinforcement Learning	Procedure	New computer based procedure for determining dose using a decision support tool	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent in Range	Percent of INR measurements within the Target Range	6 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	Composite of all adverse events attributed to warfarin	6 Months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020141	Hemostatic Disorders

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000098408	Reinforcement Machine Learning

Ancestor Terms

ID	Term
D000069550	Machine Learning
D001185	Artificial Intelligence
D000465	Algorithms
D055641	Mathematical Concepts

Browse Leaves

Not provided

Browse Branches

Not provided

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.