Point of Care Testing to Improve Monitoring of LVAD Patients
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 6/15/2018 |
| Start Date: | October 1, 2019 |
| End Date: | June 30, 2020 |
| Contact: | Han Billard, MD |
| Email: | han.billard@duke.edu |
| Phone: | 919-385-2306 |
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.
"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.
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
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