Point of Care Testing to Improve Monitoring of LVAD Patients

Not Applicable

Withdrawn

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

• Registration Number: NCT03555552
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-13
• Study Start: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09
• Primary Completion: 2024-07-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duke Central Automated Laboratory (DCAL)	Duke Central Automated Laboratory (DCAL)	-
Duke Central Automated Laboratory (DCAL)	Anticoagulation and Thrombosis Point of Care Test(AT-POCT)	-
Anticoagulation and Thrombosis Point of Care Test (AT-POCT)	Anticoagulation and Thrombosis Point of Care Test(AT-POCT)	-
Anticoagulation and Thrombosis Point of Care Test (AT-POCT)	Duke Central Automated Laboratory (DCAL)	-

Primary Outcome Measures

Name	Time	Method
Interclass correlation between PT/INR and LDH measurements	1 study day	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States