HemoSonics-UVA Spinal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Deformity of Spine
• Intervention / Treatment: Other: Procedure: Blood specimen collection

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants for this study will be recruited at the University of Virginia Medical Center. The subject population will be representative of the local racial and ethnic population.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: HemoSonics LLC
• Investigators: Principal Investigator: Bhiken Naik, MD, UVA Anethesiology Faculty

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 17942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No