QStat in Liver Transplant

Completed

• Conditions: Blood Loss, Surgical
• Interventions: Diagnostic Test: Quantra System

• Registration Number: NCT04114253
• Lead Sponsor: HemoSonics LLC

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.

Study Timeline

• Study Start: 2019-09-04
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Primary Completion: 2020-08-12
• Status Verified: 2020-12
• Study Completion: 2020-12-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver transplant patients	Quantra System	Adult patients undergoing deceased donor liver transplantation.

Primary Outcome Measures

Name	Time	Method
Comparison of Quantra Clot Time results to TEG R results	During surgery	Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Stiffness results to TEG MA results	During surgery	Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Lysis results to TEG LI30 results	During surgery	Coagulation function assessed by Quantra and TEG 5000

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States