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

Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685097
• Other study ID #: HEMCS-013
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders

Intervention

Diagnostic Test:
• Quantra System with the QPlus Cartridge
Point-of-care viscoelastic testing

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	Milan

Sponsors (2)

Lead Sponsor	Collaborator
HemoSonics LLC	IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)