HemoSonics-UVA Spinal Surgery

HemoSonics-UVA Spinal Surgery Clinical Study Protocol

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02418923

Enrollment

Registered

2015-04-17

Start date

2015-04-30

Completion date

2015-08-31

Last updated

2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deformity of Spine

Brief 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

Interventions

OTHERProcedure: Blood specimen collection

Blood specimen collection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
assay inter-instrument variability	1 day	Demonstrate assay inter-instrument variability below 15%
Establish normal ranges	1 day	Establish normal ranges

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026