Clotting DisorderPhase 4NCT03962400
Reinforcement Learning for Warfarin Dosing
A Phase 4 study testing Reinforcement Learning and Heath Care Provider in people with Clotting Disorder, run by University of Louisville.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clotting Disorder
- What is being tested?
- Reinforcement Learning and Heath Care Provider
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving anticoagulation treatment with warfarin.
Who cannot join
- 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.
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- 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.
About this study
Official title: Randomized Trial of Reinforcement Learning for the Dosing of Warfarin
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.
Read the 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.
- Conditions
- Clotting Disorder
- Being tested
- Reinforcement Learning, Heath Care Provider
- Keywords
- warfarin
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforcement LearningProcedure or surgery
New computer based procedure for determining dose using a decision support tool
Heath Care ProviderProcedure or surgery
Warfarin dose will be determined by a qualified health care provider
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects will have warfarin dose determined in the usual fashion by a health care provider. Receives: Procedure: Heath Care Provider |
| Treatment | Experimental | Subjects will have warfarin dose determined using a reinforcement learning computer model. Receives: Procedure: Reinforcement Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent in Range
Percent of INR measurements within the Target Range
Measured: 6 months
Secondary outcomes (1)
Adverse Events
Composite of all adverse events attributed to warfarin
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clotting DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Edward Gaweda, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962400
- Sponsor's protocol ID
- KDP002
- Status last verified
- Feb 2022
- First submitted
- 21 May 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Reinforcement Learning for the Dosing of Warfarin
- ClinicalTrials.gov ID
- NCT03962400
- Acronym / sponsor ID
- KDP002
- Conditions
- Clotting Disorder
- Keywords
- warfarin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Heath Care ProviderSubjects will have warfarin dose determined in the usual fashion by a health care provider. |
| Treatment | Experimental | Procedure: Reinforcement LearningSubjects will have warfarin dose determined using a reinforcement learning computer model. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving anticoagulation treatment with warfarin.
Key exclusion criteria (10 listed)
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinforcement LearningNew computer based procedure for determining dose using a decision support tool | Procedure or surgery | Treatment |
| Heath Care ProviderWarfarin dose will be determined by a qualified health care provider | Procedure or surgery | Control |
Primary outcome
Percent in Range
Time frame: 6 months
Percent of INR measurements within the Target Range
1 secondary outcome
Adverse Events
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reinforcement Learning and Heath Care Provider in people with Clotting Disorder, run by University of Louisville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent in Range (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.