NCT03555552

Point of Care Testing to Improve Monitoring of LVAD Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Anticoagulation 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.
DEVICE	Duke 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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-07-30
• Completion: 2024-08-30
• First posted: 2018-06-13
• Last updated: 2023-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study