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Point of Care Testing to Improve Monitoring of LVAD Patients

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ClinicalTrials.gov Identifier: NCT03555552
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anticoagulation and Thrombosis Point of Care Test (AT-POCT) Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT) Device: Duke Central Automated Laboratory (DCAL) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Point of Care Testing to Improve Monitoring of LVAD Patients
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anticoagulation and Thrombosis Point of Care Test (AT-POCT) 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.
Active Comparator: Duke Central Automated Laboratory (DCAL) 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.


Outcome Measures
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Primary Outcome Measures :
  1. Interclass correlation between PT/INR and LDH measurements [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555552


Contacts
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Contact: Han Billard, MD 919-385-2306 han.billard@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Contact: Han Billard, MD    919-385-2306    han.billard@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Ashutosh Chilkoti, PhD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03555552    
Other Study ID Numbers: Pro00089633
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases