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

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ClinicalTrials.gov Identifier: NCT03685097
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
IRCCS Policlinico S. Donato
Information provided by (Responsible Party):
HemoSonics LLC

Study Description
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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.

Condition or disease Intervention/treatment
Coagulation Disorder Diagnostic Test: Quantra System with the QPlus Cartridge

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 Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : August 31, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Cardiac surgery patients
Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass.
 Diagnostic Test: Quantra System with the QPlus Cartridge
Point-of-care viscoelastic testing


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results [ Time Frame: Baseline (before surgery) ]
    Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta

  2. Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta [ Time Frame: After cardiac bypass (10 minutes after administration of protamine) ]
    Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta

  3. Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results [ Time Frame: Baseline (before surgery) ]
    Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests

  4. Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results [ Time Frame: After cardiac bypass (10 minutes after administration of protamine) ]
    Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests


Secondary Outcome Measures :
  1. Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest [ Time Frame: Baseline (before surgery) ]
    Platelet function assessed by Quantra QPlus Cartridge and MEA

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes subjects 18 years or older undergoing cardiac surgery with cardiopulmonary bypass.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685097


Locations
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Italy
IRCCS Policlinico San Donato
Milan, Italy
Sponsors and Collaborators
HemoSonics LLC
IRCCS Policlinico S. Donato
Investigators
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Principal Investigator: Marco Ranucci, MD IRCCS Policlinico San Donato (Milan) Italy
More Information
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Responsible Party: HemoSonics LLC
ClinicalTrials.gov Identifier: NCT03685097    
Other Study ID Numbers: HEMCS-013
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders