Clinical trial NCT03685097: Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays
Official title: Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
Collaborators: name: IRCCS Policlinico S. Donato
First posted: 2018-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes subjects 18 years or older undergoing cardiac surgery with cardiopulmonary bypass.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results
timeFrame: Baseline (before surgery)
measure: Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta
timeFrame: After cardiac bypass (10 minutes after administration of protamine)
measure: Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results
timeFrame: Baseline (before surgery)
measure: Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results
timeFrame: After cardiac bypass (10 minutes after administration of protamine)
Secondary outcomes:
measure: Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest
timeFrame: Baseline (before surgery)
measure: Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest
timeFrame: After cardiac bypass (10 minutes after administration of protamine)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
Study officials:
affiliation: IRCCS Policlinico San Donato (Milan) Italy
name: Marco Ranucci, MD
role: PRINCIPAL_INVESTIGATOR
References: