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出境医 / 临床实验 / Reinforcement Learning for Warfarin Dosing

Reinforcement Learning for Warfarin Dosing

Study Description
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.

Condition or disease Intervention/treatment Phase
Clotting Disorder Procedure: Reinforcement Learning Procedure: Heath Care Provider Phase 4

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Masking Description: Subjects will not be informed of group designation
Primary Purpose: Treatment
Official Title: Randomized Trial of Reinforcement Learning for the Dosing of Warfarin
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Control
Subjects will have warfarin dose determined in the usual fashion by a health care provider.
Procedure: Heath Care Provider
Warfarin dose will be determined by a qualified health care provider

Experimental: Treatment
Subjects will have warfarin dose determined using a reinforcement learning computer model.
Procedure: Reinforcement Learning
New computer based procedure for determining dose using a decision support tool

Outcome Measures
Primary Outcome Measures :
  1. Percent in Range [ Time Frame: 6 months ]
    Percent of INR measurements within the Target Range


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 6 Months ]
    Composite of all adverse events attributed to warfarin


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date March 19, 2021
Estimated Study Start Date  ICMJE January 1, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Percent in Range [ Time Frame: 6 months ]
Percent of INR measurements within the Target Range
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Adverse Events [ Time Frame: 6 Months ]
Composite of all adverse events attributed to warfarin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reinforcement Learning for Warfarin Dosing
Official Title  ICMJE Randomized Trial of Reinforcement Learning for the Dosing of Warfarin
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Masking Description:
Subjects will not be informed of group designation
Primary Purpose: Treatment
Condition  ICMJE Clotting Disorder
Intervention  ICMJE
  • Procedure: Reinforcement Learning
    New computer based procedure for determining dose using a decision support tool
  • Procedure: Heath Care Provider
    Warfarin dose will be determined by a qualified health care provider
Study Arms  ICMJE
  • Active Comparator: Control
    Subjects will have warfarin dose determined in the usual fashion by a health care provider.
    Intervention: Procedure: Heath Care Provider
  • Experimental: Treatment
    Subjects will have warfarin dose determined using a reinforcement learning computer model.
    Intervention: Procedure: Reinforcement Learning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962400
Other Study ID Numbers  ICMJE KDP002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adam Edward Gaweda, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Louisville
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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