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
30 participants
OBSERVATIONAL
2019-09-04
2020-12-12
Brief Summary
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Detailed Description
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This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Liver transplant patients
Adult patients undergoing deceased donor liver transplantation.
Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Interventions
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Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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HemoSonics LLC
INDUSTRY
Responsible Party
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Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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HEMCS-029
Identifier Type: -
Identifier Source: org_study_id
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