HemoSonics - UTMB Cardiac Surgery Study

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.

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, and ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.

This single-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

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 cardiac surgery utilizing cardiopulmonary bypass, including placement of a ventricular access device.

Description

Inclusion Criteria:

• Subject is ≥ 18 years
• Subject is scheduled for cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
• Subject is willing to participate, and he/she has signed a consent form.

Exclusion Criteria:

• Subject is younger than 18 years
• Subject is unable to provide written informed consent
• Subject is incarcerated at the time of the study
• Subject is pregnant
• 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?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Surgery Patients; Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device.	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: Quantra QPlus Cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	During bypass
Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	During bypass
Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)	Coagulation function assessed by Quantra and standard coagulation tests	Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results	Coagulation function assessed by Quantra and standard coagulation tests	Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count	Coagulation function assessed by Quantra and standard coagulation tests	Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)	Coagulation function assessed by Quantra and standard coagulation tests	During bypass
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results	Coagulation function assessed by Quantra and standard coagulation tests	During bypass
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count	Coagulation function assessed by Quantra and standard coagulation tests	During bypass
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)	Coagulation function assessed by Quantra and standard coagulation tests	Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results	Coagulation function assessed by Quantra and standard coagulation tests	Post-bypass, 10 to 20 minutes after protamine
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count	Coagulation function assessed by Quantra and standard coagulation tests	Post-bypass, defined as 10 to 20 minutes after protamine administration

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 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-024

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.: No