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

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HemoSonics

Status

Completed

Conditions

Coagulation Disorder

Treatments

Diagnostic Test: Quantra System with the QPlus Cartridge

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03685097
HEMCS-013

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

30 participants in 1 patient group

Cardiac surgery patients
Description:
Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass.
Treatment:
Diagnostic Test: Quantra System with the QPlus Cartridge

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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