Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays

This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.

Study Overview

• Status: Completed
• Conditions: Coagulation Disorder
• Intervention / Treatment: Diagnostic test: Quantra System with the QPlus Cartridge

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 (previously called the Surgical Cartridge), was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge provides six parameters that depict the functional status of a patient's coagulation system.

This single site, prospective observational study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests (PT, aPTT, fibrinogen, platelet count) in cardiac surgery patients. As an additional exploratory study, the association of Quantra-derived parameters with select platelet function tests will be investigated.

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

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • IRCCS Policlinico San Donato

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 with cardiopulmonary bypass.

Description

Inclusion Criteria:

• Subject is >18 years
• Subject is undergoing elective cardiac surgery with cardiopulmonary bypass
• Subject is willing to participate and has signed a consent form

Exclusion Criteria:

• Subject is younger than 18 years
• Subject has known congenital coagulopathy
• Subject is unable to provide written informed consent

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 elective cardiac surgery requiring cardiopulmonary bypass.	Diagnostic test: Quantra System with the QPlus Cartridge; Point-of-care viscoelastic testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results	Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta	Baseline (before surgery)
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta	Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta	After cardiac bypass (10 minutes after administration of protamine)
Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results	Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests	Baseline (before surgery)
Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results	Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests	After cardiac bypass (10 minutes after administration of protamine)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest	Platelet function assessed by Quantra QPlus Cartridge and MEA	Baseline (before surgery)
Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest	Platelet function assessed by Quantra QPlus Cartridge and MEA	After cardiac bypass (10 minutes after administration of protamine)

Collaborators and Investigators

• Sponsor: HemoSonics LLC
• Collaborators: IRCCS Policlinico S. Donato
• Investigators: Principal Investigator: Marco Ranucci, MD, IRCCS Policlinico San Donato (Milan) Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: HEMCS-013

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