Status:
COMPLETED
Quantra QStat in Trauma and Liver Transplant
Lead Sponsor:
HemoSonics LLC
Conditions:
Hemorrhage
Trauma
Eligibility:
All Genders
18+ years
Brief Summary
This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.
Detailed Description
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole ...
Eligibility Criteria
Inclusion
- Subject is \> 18 years
- Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
- Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent.
Exclusion
- Subject is younger than 18 years of age
- Subject is pregnant.
- Subject is incarcerated at the time of the study.
- Subject is currently enrolled in a distinct study that might confound the result of the proposed study
- Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT04312958
Start Date
July 20 2020
End Date
April 13 2023
Last Update
May 3 2023
Active Locations (10)
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1
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
2
University of Colorado
Denver, Colorado, United States, 28037
3
University of Florida Health Shands Hospital
Gainesville, Florida, United States, 32608
4
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 98109