Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03152461
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
HemoSonics LLC

Brief Summary:
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and vascular procedures and major orthopedic surgery (primarily complex spine surgeries).

Condition or disease Intervention/treatment
Blood Loss, Surgical Diagnostic Test: Quantra System

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 Surgical 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 multi-center, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using the ROTEM Delta.

Layout table for study information
Study Type : Observational
Actual Enrollment : 302 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge in Adult Patients Undergoing Major Surgical Procedures
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

Group/Cohort Intervention/treatment
Surgical patients
Patients undergoing elective cardiac or vascular surgery involving bypass, or major spine surgery, or surgical patients presenting with acute bleeding in a post-surgical unit.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Name: Quantra Surgical Cartridge




Primary Outcome Measures :
  1. Comparison of Quantra Clot Time and Clot Stiffness results to standard coagulation test results [ Time Frame: Baseline, during surgery, and up to 24 hours post-surgery ]
    Coagulation function assessed by Quantra and standard coagulation tests

  2. Comparison of Quantra Clot Time and Clot Stiffness results to comparable ROTEM Delta results [ Time Frame: Baseline, during surgery, and up to 24 hours post-surgery ]
    Coagulation function assessed by Quantra and ROTEM Delta



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 a surgical procedure with high risk of intra- or post-operative bleeding. It is anticipated that approximately two-thirds of the enrolled subjects will be cardiac or vascular surgery patients and one-third will be orthopedic surgery patients.
Criteria

Inclusion Criteria:

  • Subject is ≥18 years
  • Subject is scheduled for either 1) cardiac or vascular surgery utilizing cardiopulmonary bypass (CPB) or 2) orthopedic surgery including major deformity correction spine surgery
  • Subject has a cardiac assist device and is hospitalized for any procedure
  • Subject underwent cardiac, vascular or orthopedic surgery and presents with acute bleeding or suspected hypercoagulability in a post-surgical unit
  • Subject is undergoing emergency cardiac, vascular or orthopedic surgery
  • Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

  • Subject is unable to provide written informed consent
  • Subject is younger than 18 years
  • Subject is incarcerated at the time of the study
  • Subject is pregnant
  • Subject is currently enrolled in a study that might confound the result of the proposed study
  • Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks

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): NCT03152461


Locations
Layout table for location information
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27703
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
HemoSonics LLC

Layout table for additonal information
Responsible Party: HemoSonics LLC
ClinicalTrials.gov Identifier: NCT03152461    
Other Study ID Numbers: HEMCS-008
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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.: No
Keywords provided by HemoSonics LLC:
Viscoelastic testing
Coagulation
Quantra
Hemostasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications