Quantra QStat Sample Type Comparison

Impact of Sample Type on the Performance of the Quantra QStat System

This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.

Study Overview

• Status: Completed
• Conditions: Coagulation Defect; Bleeding
• Intervention / Treatment: Device: Diagnostic Test: Quantra QStat Cartridge

Detailed Description

In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing liver transplant surgery.

Description

Inclusion Criteria:

• Subject is >=18 years
• Subject is scheduled for liver transplant surgery
• Subject or subject's legally authorized representative (LAR) is willing to provide 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 affected by a condition that, in the opinion of the treatment team, may pose additional risks
• Subject, or subject's LAR, is unable or unwilling to provide informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of QStat Clot time (CT) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery
Comparison of QStat Clot stiffness (CS) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery
Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery
Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery
Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples	Coagulation function assessed in two sample types	During liver transplantation surgery

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Liver transplantation; Coagulation; Quantra
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: HEMCS-046

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