Clinical trial NCT04114253: QStat in Liver Transplant
Official title: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Liver Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss, Surgical
Keywords: Viscoelastic testing
Coagulation
Quantra
Hemostasis
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes subjects 18 years or older undergoing deceased donor liver transplant.

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 blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Comparison of Quantra Clot Time results to TEG R results
timeFrame: Baseline, after induction of anesthesia, before surgical incision
measure: Comparison of Quantra Clot Stiffness results to TEG MA results
timeFrame: Baseline, after induction of anesthesia, before surgical incision
measure: Comparison of Quantra Clot Lysis results to TEG LI30 results
timeFrame: Baseline, after induction of anesthesia, before surgical incision
measure: Comparison of Quantra Clot Time results to TEG R results
timeFrame: During surgery
measure: Comparison of Quantra Clot Stiffness results to TEG MA results
timeFrame: During surgery
measure: Comparison of Quantra Clot Lysis results to TEG LI30 results
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: