Point of Care Testing to Improve Monitoring of LVAD Patients

Study Overview
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Brief Summary
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The purpose of this study is to develop and validate the accuracy of a low-cost point-of-care test (POCT) that allows monitoring of markers for anticoagulation and thrombosis (local coagulation or clotting of the blood), to be used by patients with advanced heart failure (AHF) on left ventricular assist device (LVAD) support. The investigators central hypothesis is that the fully-printed AT-POCT utilizing low-cost (printed) cassettes and detector will produce an inexpensive and convenient option for daily self-monitoring of PT/INR and LDH over existing methods.

Official Title
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Point of Care Testing to Improve Monitoring of LVAD Patients

Conditions
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Anticoagulation and Thrombosis Point of Care Test (AT-POCT)

Intervention / Treatment
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* Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT)
* Device: Duke Central Automated Laboratory (DCAL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age Subject has signed Informed Consent Form (ICF) For LVAD patient cohort, they are on LVAD support from 2 weeks to 10 years. Exclusion Criteria: Patients with dementia, altered mental status, any psychiatric condition or mental disability that would prohibit the understanding or rendering of informed consent are not eligible Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anticoagulation and Thrombosis Point of Care Test (AT-POCT)<br> | Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT)<br>* Capillary action automatically draws blood into the channel containing printed assay reagents which solubilize upon contact with blood and react with analytes of interest.<br>Device: Duke Central Automated Laboratory (DCAL)<br>* DCAL measurement of INR will occur by an ACL TOP 750 Analyzer (IL Inc.), and LDH by standard enzymatic activity assay will be run on the automated Beckman DxC800.<br>|
| Active Comparator: Duke Central Automated Laboratory (DCAL)<br> | Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT)<br>* Capillary action automatically draws blood into the channel containing printed assay reagents which solubilize upon contact with blood and react with analytes of interest.<br>Device: Duke Central Automated Laboratory (DCAL)<br>* DCAL measurement of INR will occur by an ACL TOP 750 Analyzer (IL Inc.), and LDH by standard enzymatic activity assay will be run on the automated Beckman DxC800.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interclass correlation between PT/INR and LDH measurements | The primary outcome is acceptable inter-rater agreement between our measure and the clinical gold standards for both PT/INR and LDH. This will be defined as an interclass correlation of > 0.8 with a CI lower bound of 0.1 based on the sample size of this study. | 1 study day |