Point of Care Testing to Improve Monitoring of LVAD Patients

NCT ID: NCT03555552

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-08-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Capillary action automatically draws blood into the channel containing printed assay reagents which solubilize upon contact with blood and react with analytes of interest.

Duke Central Automated Laboratory (DCAL)

Intervention Type: DEVICE

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.

Duke Central Automated Laboratory (DCAL)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Capillary action automatically draws blood into the channel containing printed assay reagents which solubilize upon contact with blood and react with analytes of interest.

Duke Central Automated Laboratory (DCAL)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashutosh Chilkoti, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00089633

Identifier Type: -

Identifier Source: org_study_id