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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03685097

Enrollment

Registered

2018-09-26

Start date

2018-03-01

Completion date

2018-08-31

Last updated

2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder

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.

Interventions

DIAGNOSTIC_TESTQuantra System with the QPlus Cartridge

Point-of-care viscoelastic testing

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	Baseline (before surgery)	Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests

Secondary

Measure	Time frame	Description
Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest	Baseline (before surgery)	Platelet function assessed by Quantra QPlus Cartridge and MEA

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026