Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge
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 Quantra Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and vascular procedures and major orthopedic surgery (primarily complex spine surgeries).
Key facts
- Study ID
- NCT03152461
- Run by
- HemoSonics LLC
- People needed
- 302
- Starts
- 2017-05-23
- Expected to finish
- 2018-02-09
- Last updated by the study team
- 2018-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is ≥18 years
- Subject is scheduled for either 1) cardiac or vascular surgery utilizing cardiopulmonary bypass (CPB) or 2) orthopedic surgery including major deformity correction spine surgery
- Subject has a cardiac assist device and is hospitalized for any procedure
- Subject underwent cardiac, vascular or orthopedic surgery and presents with acute bleeding or suspected hypercoagulability in a post-surgical unit
- Subject is undergoing emergency cardiac, vascular or orthopedic surgery
- Subject is willing to participate and he/she has signed a consent form
You may not qualify if…
- Subject is unable to provide written informed consent
- Subject is younger than 18 years
- Subject is incarcerated at the time of the study
- Subject is pregnant
- Subject is currently enrolled in a study that might confound the result of the proposed study
- Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
Where it is running
- University of Maryland Medical Center — Baltimore, Maryland, United States
- Duke University School of Medicine — Durham, North Carolina, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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