UnknownNot Applicable

Assessment of Platelet Function in Patients Undergoing Open Heart Surgery

United States75 participantsStarted 2022-03-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is at least 18 years of age * Subject scheduled for elective cardiothoracic surgery requiring a sternotomy * Coronary artery bypass grafting (CABG) * Combined CABG and valve surgery * On-pump double or triple valve procedures * Aortic surgery or redo surgery * Off pump CABG as part of a hybrid revascularization approach * Able to read and has signed and dated the informed consent form Exclusion Criteria: * Subject requiring an emergency procedure * Pregnancy * Subject is hemodynamically unstable * Conversion to on-pump * History of bleeding tendencies * History of coagulation disorders

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

System functionality and analytical performance of Saturn Investigational Instrument and Cartridge

Timeframe: 48 hours after open heart surgery

Trial details

NCT IDNCT05441358

SponsorLifeBridge Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-01

Contact for this trial

Kevin Bliden, MBA

410-601-4194 kbliden@lifebridgehealth.org

View on ClinicalTrials.gov More Coronary Artery Bypass Grafting trials