Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05441358 |
| Other study ID # |
1813901 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2022 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
June 2022 |
| Source |
LifeBridge Health |
| Contact |
Kevin Bliden, MBA |
| Phone |
410-601-4194 |
| Email |
kbliden[@]lifebridgehealth.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this external evaluation is to assess the system functionality and analytical
performance of the Saturn Investigational Instrument (next generation VerifyNow instrument)
and associated cartridge currently under development.
A single test cartridge with multiple assays will be compared with Light Transmittance
Aggregometry (LTA) within a clinical setting using blood samples. Analytical performance will
be compared between these assays. The outcome of this evaluation will be used to demonstrate
baseline performance and support the design and development of the Saturn analyzer and
optimization of the associated algorithm.
Description:
This protocol applies to the evaluation of the Saturn Investigational Instrument and
cartridge. LTA will serve as the reference analyzer for this study. The evaluation will be
conducted at Sinai Hospital ( Baltimore, Maryland).
The Sponsor has determined that this investigation is classified as a non-significant risk
study. While there are risks associated with the cardiac procedure, there is minimal
additional risk associated with having blood specimen collection during the standard of care
operation.
Risks to the operator include potential exposure to blood-borne pathogens if a patient's
blood specimen is infected. The risk is mitigated by only allowing trained personnel to
participate in the study.
Results obtained from the investigational device shall not be used for any clinical
assessments, decisions, or treatments for any subjects enrolled in the study, or any patients
not enrolled in the study. No study-specific test results shall be provided to the subject.
Study-specific test results will only be accessible by personnel duly trained to the study
protocol and authorized for use of the study analyzers and/or study-specific data capture
systems.
Project Saturn is the next generation VerifyNow System. The System includes an analyzer,
single-use test cartridges, and associated quality controls. Project Saturn will be developed
and commercialized in two phases. Phase 1 includes a modern analyzer which will perform the
current, on-market VerifyNow Tests: PRUTest and Aspirin Test. Phase 2 will utilize the Phase
1 Saturn analyzer and test menu to expand the capacity beyond antiplatelet therapy (APT)
assessment and monitoring to include general platelet dysfunction that is not APT-specific.
The Phase 2 analyzer will utilize an updated algorithm that can reliably conduct platelet
function measurements over an expanded hematocrit range (≥21% HCT) and will have an increased
menu offering.
At a minimum, data analysis will be performed using the latest version of CLSI EP09-A3 and
EP12-A2 as guidelines with Analyse-it/Microsoft Excel or similar software. Additional
analysis may be added as required.
The estimated sample size in this study is expected to yield results to allow continued
development of the Saturn Investigational Instrument and is based on prior translational
clinical experience with similar device development activities. There has been no formal
power analysis, and the population size is not intended to support a regulatory submission.
The purpose of this evaluation is to gain information on the system functionality and
analytical performance of the Saturn Investigational Instrument using whole blood samples.
One Saturn cartridge will be tested in parallel with Chronolog LTA for each patient.
This is an observational study that will be conducted in patients undergoing open heart
surgery. The outcome of this evaluation will be used to inform future development activities.
Data will not be used in a regulatory submission.
Recruitment will occur at Sinai Hospital of Baltimore. The expected length of recruitment
period is up to 6 months. A minimum of 75 patients are expected to participate in this trial.
Patient participation will entail pre-, intra-, and peri-operative phlebotomy up to 48 hours
after surgery. In-hospital clinical and outcome data will be collected. Subject consent to
participate in the research will be documented by the investigator per the institution
policies regarding informed consent and 21 CFR part 50.
The screening process will consist of routine preoperative screening, which is part of the
standard of care prior to cardiac surgery. Preoperative medical evaluation will include
review of patient's history, physical examination, and available cardiac and other diagnostic
risks for the proposed operation. Those who meet all inclusion criteria and none of the
exclusionary criteria are eligible for enrollment.
All patients will undergo standardized anesthesia and surgical protocol. Blood samples will
be collected and analyzed at the following timepoints: pre-anesthesia, immediately
post-protamine (off pump), 1-2 hours post-protamine and up to 48 hours post-surgical
completion. A total of up to 60 ml (up to 15ml at each timepoint) of blood will be collected
for research purposes throughout the study duration. Blood sampling will be obtained via a
central venous catheter or direct phlebotomy depending on the time of CVC discontinuation.
Medical records will be reviewed to assess for in-hospital serious adverse events and to
document blood loss, bleeding events, and blood transfusion requirements.
All laboratory assessments will be completed prior to anesthesia induction, immediately
post-protamine, 1-2 hours post-protamine and up to 48 hours post-surgical completion.
- Saturn Investigational Cartridge
- Light transmittance platelet aggregation stimulated by collagen, ADP, TRAP, and
arachidonic acid
- CBC
The study is comprised of 4 periods: Preoperative and screening, during surgery, after
surgical completion, and in-hospital pre-discharge. The preoperative and screening period is
comprised of baseline assessments and assessment of safety laboratory values and platelet
function testing. During surgery and after surgical completion assessments are comprised of
safety laboratory and platelet function testing while in-hospital pre-discharge assessment is
comprised mainly of adverse and bleeding events via medical records review.
