Status:
COMPLETED
QStat in Liver Transplant
Lead Sponsor:
HemoSonics LLC
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
18+ years
Brief Summary
This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.
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 propoerties of a whole...
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years of age
- Subject is undergoing deceased donor liver transplant and is a candidate for a TEG test to be performed to access coagulopathy during surgery.
- Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)
Exclusion
- Subject is younger than 18 years of age
- Subject is known to have received antifibrinolytic therapy immediately prior to the start of liver transplantation surgery.
- Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
- Subject is currently enrolled in a distinct study that might confound the results of the proposed study
- Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
Key Trial Info
Start Date :
September 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04114253
Start Date
September 4 2019
End Date
December 12 2020
Last Update
January 5 2021
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455