- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03931031
Recruitment Status Completed
First Posted April 29, 2019
Last update posted July 1, 2020
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.
|: Cardiac Surgery Patients
Patients taking antiplatelet medication who are scheduled for elective cardiac surgery.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass,
including the placement of a ventricular assist device
- Subject was identified as taking antiplatelet medication, specifically a P2Y12
inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to
assess possible platelet inhibition
- Subject is ≥ 18 years
- Subject is willing to participate and he/she has signed a consent form
- Subject is younger that 18 years
- Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject is pregnant
- Subject is currently enrolled in a distinct study that might confound the results of
the proposed study
- Subject is affected by a condition that, in the opinion of the clinical team, may pose
United States, Alabama