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Point of Care Testing to Improve Monitoring of LVAD Patients

NCT03555552 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Ashutosh Chilkoti, PhD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-07-30
Completion
2024-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555552 on ClinicalTrials.gov