Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2015-04-30
2015-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Procedure: Blood specimen collection
Blood specimen collection
Eligibility Criteria
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Inclusion Criteria
* Subject is older than 18 years
* Subject is willing to participate and he/she has signed a consent form
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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HemoSonics LLC
INDUSTRY
University of Virginia
OTHER
Responsible Party
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Bhiken I. Naik, MD
UVA Anesthesiology Faculty
Principal Investigators
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Bhiken Naik, MD
Role: PRINCIPAL_INVESTIGATOR
UVA Anethesiology Faculty
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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17942
Identifier Type: -
Identifier Source: org_study_id
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