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| Name | Class |
|---|---|
| HemoSonics LLC | INDUSTRY |
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This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.
HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.
Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.
A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: Blood specimen collection | Other | Blood specimen collection |
| Measure | Description | Time Frame |
|---|---|---|
| assay inter-instrument variability | Demonstrate assay inter-instrument variability below 15% | 1 day |
| Establish normal ranges | Establish normal ranges | 1 day |
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Inclusion Criteria:
• Subject is scheduled for major deformity correction spine surgery
Exclusion Criteria:
• Subject is unable to provide written informed consent
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Participants for this study will be recruited at the University of Virginia Medical Center. The subject population will be representative of the local racial and ethnic population.
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| Name | Affiliation | Role |
|---|---|---|
| Bhiken Naik, MD | UVA Anethesiology Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
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