Back to resultsPoint of Care Testing to Improve Monitoring of LVAD Patients
Primary Purpose
Anticoagulation and Thrombosis Point of Care Test (AT-POCT)
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anticoagulation and Thrombosis Point of Care Test(AT-POCT)
Duke Central Automated Laboratory (DCAL)
Sponsored by
About this trial
This is an interventional diagnostic trial for Anticoagulation and Thrombosis Point of Care Test (AT-POCT)
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anticoagulation and Thrombosis Point of Care Test (AT-POCT)
Duke Central Automated Laboratory (DCAL)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03555552
Brief Title
Point of Care Testing to Improve Monitoring of LVAD Patients
Official Title
Point of Care Testing to Improve Monitoring of LVAD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely, prior to enrollment of first participant
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulation and Thrombosis Point of Care Test (AT-POCT)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anticoagulation and Thrombosis Point of Care Test (AT-POCT)
Arm Type
Experimental
Arm Title
Duke Central Automated Laboratory (DCAL)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Anticoagulation and Thrombosis Point of Care Test(AT-POCT)
Intervention Description
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
Intervention Name(s)
Duke Central Automated Laboratory (DCAL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Interclass correlation between PT/INR and LDH measurements
Description
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.
Time Frame
1 study day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashutosh Chilkoti, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Point of Care Testing to Improve Monitoring of LVAD Patients
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