Point of Care Testing to Improve Monitoring of LVAD Patients

Duke University

Status: Withdrawn

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

Treatments: Device: Duke Central Automated Laboratory (DCAL); Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03555552

Pro00089633

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

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

Experimental group

Treatment:

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

Device: Duke Central Automated Laboratory (DCAL)

Duke Central Automated Laboratory (DCAL)

Active Comparator group

Treatment:

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

Device: Duke Central Automated Laboratory (DCAL)