Assessment of Platelet Function in Patients Undergoing Open Heart Surgery

Status unconfirmed

Conditions studied: Coronary Artery Bypass Grafting, Open Heart Surgery, Aortic Surgery or Redo Surgery, On-pump Double or Triple Valve Procedures

In brief

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.

Key facts

Study ID: NCT05441358
Run by: LifeBridge Health
People needed: 75
Starts: 2022-03-23
Expected to finish: 2023-01-01
Last updated by the study team: 2022-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

Subject requiring an emergency procedure
Pregnancy
Subject is hemodynamically unstable
Conversion to on-pump
History of bleeding tendencies
History of coagulation disorders

Where it is running

Sinai Center for Thrombosis Research — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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