Evaluation of the Quantra System in a Surgical Oncological Population

This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.

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 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 iin parallel yielding six parameters that depict the functional status of a patient's coagulation system.

The oncologic surgical population presents unique challenges to providers who must distinguish between a cancer patient's increased tendency toward both thrombosis and hemorrhage. This single site prospective observational study in oncologic patients will give an insight into the coagulation status of critically ill cancer patients.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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 adult subjects undergoing an oncologic surgical procedure.

Description

Inclusion Criteria:

• Subject is >= 18 years
• Subject is diagnosed with cancer and is scheduled for surgical resection
• Subject is willing to participate, and he/she or a Legally Authorized Representative (LAR) has signed a consent form
• Surgical procedure to be performed has an anticipated blood loss (>500mL) based on historical data

Exclusion Criteria:

• Subject is younger than 18 years
• Subject or a subject's LAR is unable to provide written informed consent
• Subject is undergoing an emergent procedure.
• Subject is pregnant, has active liver disease, or severe renal dysfunction (creatinine clearance (CrCL)<30 mL/min)
• Subject has an extremely low platelet count (<40,000/uL)
• 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
Cancer surgery patients; Adult subjects (18 years or older) undergoing an oncologic surgical procedure.	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: Quantra QPlus System

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, 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, before surgical incision
Comparison of Quantra Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	During surgery
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	Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery
Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 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-025

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