HemoSonics-UVA Spinal Surgery
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/12/2016 |
Start Date: | April 2015 |
End Date: | August 2015 |
HemoSonics-UVA Spinal Surgery Clinical Study Protocol
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.
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
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
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)
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