QStat in Liver Transplant

Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Liver Transplant

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

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Diagnostic test: Quantra System

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes subjects 18 years or older undergoing deceased donor liver transplant.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Liver transplant patients; Adult patients undergoing deceased donor liver transplantation.	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: Quantra QStat Cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	During surgery
Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	Baseline, after induction of anesthesia, before surgical incision
Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	Baseline, after induction of anesthesia, before surgical incision
Comparison of Quantra Clot Lysis results to TEG LI30 results	Coagulation function assessed by Quantra and TEG 5000	Baseline, after induction of anesthesia, before surgical incision
Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	During surgery
Comparison of Quantra Clot Lysis results to TEG LI30 results	Coagulation function assessed by Quantra and TEG 5000	During surgery

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2019
• Primary Completion (ACTUAL): August 12, 2020
• Study Completion (ACTUAL): December 12, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (ACTUAL): October 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Hemostasis; Coagulation; Quantra; Viscoelastic testing
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical
• Other Study ID Numbers: HEMCS-029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes