Anticoagulation and Thrombosis Point of Care Test (AT-POCT)
Conditions
Brief summary
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.
Interventions
DEVICEAnticoagulation and Thrombosis Point of Care Test(AT-POCT)
Capillary action automatically draws blood into the channel containing printed assay reagents which solubilize upon contact with blood and react with analytes of interest.
DEVICEDuke Central Automated Laboratory (DCAL)
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.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interclass correlation between PT/INR and LDH measurements | 1 study day | 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. |
Countries
United States
Outcome results
None listed