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
|Condition or disease||Intervention/treatment|
|Blood Loss, Surgical||Diagnostic Test: Quantra System|
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.
|Study Type :||Observational|
|Actual Enrollment :||302 participants|
|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|
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
- 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
- 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
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
|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|