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

Completed

• Conditions: Coagulation Disorder
• Interventions: Diagnostic Test: Quantra System with the QPlus Cartridge

• Registration Number: NCT03685097
• Lead Sponsor: HemoSonics LLC

Brief Summary

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.

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 Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-24
• Last Update Submitted: 2018-09-24
• Study First Posted: 2018-09-26
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac surgery patients	Quantra System with the QPlus Cartridge	Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest	After cardiac bypass (10 minutes after administration of protamine)	Platelet function assessed by Quantra QPlus Cartridge and MEA

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 Milan, Italy