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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge in Adult Patients Undergoing Major Surgical Procedures

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).

Detailed Summary:

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.

Sponsor: HemoSonics LLC

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: HemoSonics LLC

Dates:
Date Received: May 9, 2017
Date Started: May 12, 2017
Date Completion: September 1, 2017
Last Updated: May 12, 2017
Last Verified: May 2017