NCT02418923

HemoSonics-UVA Spinal Surgery

HemoSonics-UVA Spinal Surgery Clinical Study Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Deformity of Spine

Interventions

Type	Name	Description
OTHER	Procedure: Blood specimen collection	Blood specimen collection

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-04-17
• Last updated: 2016-05-11

Locations

1 site across 1 country: United States