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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

Clinicaltrials.gov identifier NCT03931031

Recruitment Status Completed

First Posted April 29, 2019

Last update posted July 1, 2020

Study Description

Brief summary:

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

  • Condition or Disease:Blood Loss, Surgical
  • Intervention/Treatment: Diagnostic Test: Quantra System
  • Phase: N/A
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 was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 40 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
  • Actual Study Start Date: March 2019
  • Actual Primary Completion Date: April 2020
  • Actual Study Completion Date: June 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Cardiac Surgery Patients
Patients taking antiplatelet medication who are scheduled for elective cardiac surgery.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
Outcome Measures
  • Primary Outcome Measures: 1. Comparison of Quantra Clot Time test results to TEG test results. [ Time Frame: Post-bypass (10 to 20 minutes after protamine administration). ]
    Coagulation function assessed by Quantra and TEG.
  • 2. Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results. [ Time Frame: Post-bypass (10 to 20 minutes after protamine administration). ]
    Coagulation function assessed by Quantra and TEG.
  • 3. Comparison of Quantra Clot Time test results to TEG test results. [ Time Frame: Prior to surgery (Baseline) ]
    Coagulation function assessed by Quantra and TEG.
  • 4. Comparison of Quantra Clot Stiffness test results to TEG test results. [ Time Frame: Prior to surgery (Baseline) ]
    Coagulation function assessed by Quantra and TEG.
  • 5. Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen [ Time Frame: Prior to surgery (Baseline) ]
    Coagulation function assessed by Quantra and laboratory fibrinogen testing
  • 6. Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen [ Time Frame: Post-bypass (10 to 20 minutes after protamine administration). ]
    Coagulation function assessed by Quantra and laboratory fibrinogen testing
  • 7. Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count [ Time Frame: Post-bypass (10 to 20 minutes after protamine administration). ]
    Coagulation function assessed by Quantra and laboratory fibrinogen testing
  • 8. Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count [ Time Frame: Prior to surgery (Baseline) ]
    Coagulation function assessed by Quantra and platelet count
Eligibility Criteria
  • 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: Potential study participants will be adult (≥ 18 years) subjects who are taking antiplatelet medication and who are scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device.
Criteria

Inclusion Criteria:

- Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass,
including the placement of a ventricular assist device

- Subject was identified as taking antiplatelet medication, specifically a P2Y12
inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to
assess possible platelet inhibition

- Subject is ≥ 18 years

- Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

- Subject is younger that 18 years

- Subject is unable to provide written informed consent

- Subject is incarcerated at the time of the study

- Subject is pregnant

- Subject is currently enrolled in a distinct study that might confound the results of
the proposed study

- Subject is affected by a condition that, in the opinion of the clinical team, may pose
additional risks.

Contacts and Locations
Contacts
Locations

United States, Alabama
Huntsville Hospital
Huntsville

Sponsors and Collaborators

HemoSonics LLC

More Information
  • Responsible Party: HemoSonics LLC
  • ClinicalTrials.gov Identifier: NCT03931031 History of Changes
  • Other Study ID Numbers: HEMCS-017
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: July 1, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by HemoSonics LLC: Viscoelastic testing
    Coagulation
    Hemostasis
    Quantra
  • Additional relevant MeSH terms: Blood Loss, Surgical