Quantra QStat in Trauma and Liver Transplant

Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation

This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Trauma; Liver Transplant
• 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 properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.

• Study Type: Observational
• Enrollment (Actual): 397

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital and Trauma Center
  • Colorado
    • Denver, Colorado, United States, 28037
      • University of Colorado
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida Health Shands Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 98109
      • University of Michigan Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Medical Center
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Potential study participants will be adult (>18 years) trauma patients or patients undergoing liver transplant surgery.

Description

Inclusion Criteria:

• Subject is > 18 years
• Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
• Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent.

Exclusion Criteria:

• Subject is younger than 18 years of age
• Subject is pregnant.
• Subject is incarcerated at the time of the study.
• Subject is currently enrolled in a distinct study that might confound the result of the proposed study
• Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trauma patients; Trauma patients experiencing traumatic injuries requiring a full trauma team response.	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
Liver transplant patients; Patients undergoing liver transplant surgery.	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 Time (CT) to ROTEM Delta INTEM CT results	Coagulation function assessed by Quantra and ROTEM Delta	Upon arrival of trauma subject to the emergency department
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, immediately before the start of liver transplant surgery
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results	Coagulation function assessed by Quantra and ROTEM Delta	During anhepatic phase of liver transplant surgery
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results	Coagulation function assessed by Quantra and ROTEM Delta	During post-reperfusion phase of liver transplant surgery
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	Upon arrival of trauma subject to the emergency department
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, immediately before the start of liver transplant surgery
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	During anhepatic phase of liver transplant surgery
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	During post-reperfusion phase of liver transplant surgery
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	Upon arrival of trauma subject to the emergency department
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, immediately before the start of liver transplant surgery
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	During anhepatic phase of liver transplant surgery
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	During post-reperfusion phase of liver transplant surgery
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results	Coagulation function assessed by Quantra and ROTEM Delta	Upon arrival of trauma subject to the emergency department
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, immediately before the start of liver transplant surgery
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results	Coagulation function assessed by Quantra and ROTEM Delta	During anhepatic phase of liver transplant surgery
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results	Coagulation function assessed by Quantra and ROTEM Delta	During post-reperfusion phase of liver transplant surgery

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: March 15, 2020
• First Submitted That Met QC Criteria: March 15, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Trauma; Coagulation; Liver Transplant; Quantra; Viscoelastic testing; QStat
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage
• Other Study ID Numbers: HEMCS-032

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