Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge

Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge in Adult Patients Undergoing Major Surgical Procedures

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and vascular procedures and major orthopedic surgery (primarily complex spine surgeries).

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 Surgical 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 multi-center, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using the ROTEM Delta.

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke University School of Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

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 a surgical procedure with high risk of intra- or post-operative bleeding. It is anticipated that approximately two-thirds of the enrolled subjects will be cardiac or vascular surgery patients and one-third will be orthopedic surgery patients.

Description

Inclusion Criteria:

• Subject is ≥18 years
• Subject is scheduled for either 1) cardiac or vascular surgery utilizing cardiopulmonary bypass (CPB) or 2) orthopedic surgery including major deformity correction spine surgery
• Subject has a cardiac assist device and is hospitalized for any procedure
• Subject underwent cardiac, vascular or orthopedic surgery and presents with acute bleeding or suspected hypercoagulability in a post-surgical unit
• Subject is undergoing emergency cardiac, vascular or orthopedic surgery
• Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

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

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical patients; Patients undergoing elective cardiac or vascular surgery involving bypass, or major spine surgery, or surgical patients presenting with acute bleeding in a post-surgical unit.	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: Quantra Surgical Cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Quantra Clot Time and Clot Stiffness results to standard coagulation test results	Coagulation function assessed by Quantra and standard coagulation tests	Baseline, during surgery, and up to 24 hours post-surgery
Comparison of Quantra Clot Time and Clot Stiffness results to comparable ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, during surgery, and up to 24 hours post-surgery

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): February 9, 2018
• Study Completion (Actual): February 9, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

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-008

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