Clotting Disorder
Conditions
Keywords
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.
Interventions
PROCEDUREReinforcement Learning
New computer based procedure for determining dose using a decision support tool
PROCEDUREHeath Care Provider
Warfarin dose will be determined by a qualified health care provider
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will not be informed of group designation
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent in Range | 6 months | Percent of INR measurements within the Target Range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 6 Months | Composite of all adverse events attributed to warfarin |
Outcome results
None listed