HemoSonics-UVA Spinal Surgery

University of Virginia51 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Deformity of Spine

Interventions

Procedure: Blood specimen collectionOTHER

Blood specimen collection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

assay inter-instrument variability

Demonstrate assay inter-instrument variability below 15%

Time frame: 1 day

Establish normal ranges

Time frame: 1 day

Data from ClinicalTrials.gov

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