Anticoagulation and Thrombosis Point of Care Test (AT-POCT)NCT03555552
Point of Care Testing to Improve Monitoring of LVAD Patients
A study testing Anticoagulation and Thrombosis Point of Care Test(AT-POCT) and Duke Central Automated Laboratory (DCAL) in people with Anticoagulation and Thrombosis Point of Care Test (AT-POCT), run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anticoagulation and Thrombosis Point of Care Test (AT-POCT)
- What is being tested?
- Anticoagulation and Thrombosis Point of Care Test(AT-POCT) and Duke Central Automated Laboratory (DCAL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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.
- Being tested
- Anticoagulation and Thrombosis Point of Care Test(AT-POCT), Duke Central Automated Laboratory (DCAL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation and Thrombosis Point of Care Test(AT-POCT)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)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.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation and Thrombosis Point of Care Test (AT-POCT) | Experimental | Not described Receives: Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT); Device: Duke Central Automated Laboratory (DCAL) |
| Duke Central Automated Laboratory (DCAL) | Active comparator | Not described Receives: Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT); Device: Duke Central Automated Laboratory (DCAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Why it stopped: Study halted prematurely, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulation and Thrombosis Point of Care Test (AT-POCT)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashutosh Chilkoti, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555552
- Sponsor's protocol ID
- Pro00089633
- Status last verified
- Aug 2023
- First submitted
- 1 Jun 2018
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Testing to Improve Monitoring of LVAD Patients
- ClinicalTrials.gov ID
- NCT03555552
- Acronym / sponsor ID
- Pro00089633
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation and Thrombosis Point of Care Test (AT-POCT) | Experimental | Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT), Device: Duke Central Automated Laboratory (DCAL) |
| Duke Central Automated Laboratory (DCAL) | Active comparator | Device: Anticoagulation and Thrombosis Point of Care Test(AT-POCT), Device: Duke Central Automated Laboratory (DCAL) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Anticoagulation and Thrombosis Point of Care Test (AT-POCT), Duke Central Automated Laboratory (DCAL) |
| 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. | Device | Anticoagulation and Thrombosis Point of Care Test (AT-POCT), Duke Central Automated Laboratory (DCAL) |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashutosh Chilkoti, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulation and Thrombosis Point of Care Test(AT-POCT) and Duke Central Automated Laboratory (DCAL) in people with Anticoagulation and Thrombosis Point of Care Test (AT-POCT), run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interclass correlation between PT/INR and LDH measurements (time frame: 1 study day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.