Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

Completed

Conditions studied: Blood Loss, Surgical

In brief

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.

Key facts

Study ID

NCT03931031

Run by

HemoSonics LLC

People needed

40

Starts

2019-03-21

Expected to finish

2020-06-27

Last updated by the study team

2020-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 additional risks.

Where it is running

• Huntsville Hospital — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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