Point of Care Testing to Improve Monitoring of LVAD Patients

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

Official title:

Point of Care Testing to Improve Monitoring of LVAD Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03555552
• Other study ID #: Pro00089633
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interclass correlation between PT/INR and LDH measurements	The primary outcome is acceptable inter-rater agreement between our measure and the clinical gold standards for both PT/INR and LDH. This will be defined as an interclass correlation of > 0.8 with a CI lower bound of 0.1 based on the sample size of this study.	1 study day