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 range18 Years

SexALL

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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

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