HemoSonics-UVA Spinal Surgery

Completed

• Conditions: Deformity of Spine

• Registration Number: NCT02418923
• Lead Sponsor: University of Virginia

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

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-17
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assay inter-instrument variability	1 day	Demonstrate assay inter-instrument variability below 15%
Establish normal ranges	1 day	Establish normal ranges

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States