Expired Study
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Charlottesville, Virginia 22908


Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: - • Subject is scheduled for major deformity correction spine surgery - Subject is older than 18 years - Subject is willing to participate and he/she has signed a consent form Exclusion Criteria: - • Subject is unable to provide written informed consent - Subject is incarcerated at the time of the study - Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks - Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl) - Subjects with history of active liver disease - Subjects affected by Factor V Leiden mutation - Subjects affected by von Willebrand disease - Subjects with an history of thrombotic disease (more than one DVT)


NCT ID:

NCT02418923


Primary Contact:

Principal Investigator
Bhiken Naik, MD
UVA Anethesiology Faculty


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia 22908
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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