QStat in Liver Transplant

HemoSonics

Status: Completed

Conditions: Blood Loss, Surgical

Treatments: Diagnostic Test: Quantra System

Study type: Observational

Funder types: Industry

Identifiers

NCT04114253

HEMCS-029

Details and patient eligibility

About

This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Liver transplant patients

Description:

Adult patients undergoing deceased donor liver transplantation.

Treatment:

Diagnostic Test: Quantra System