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

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152461
• Other study ID #: HEMCS-008
• Status: Completed
• Start date: May 23, 2017
• Est. completion date: February 9, 2018

Study information

• Verified date: July 2018
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: February 9, 2018
• Est. primary completion date: February 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Duke University School of Medicine	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Quantra Clot Time and Clot Stiffness results to standard coagulation test results	Coagulation function assessed by Quantra and standard coagulation tests	Baseline, during surgery, and up to 24 hours post-surgery
Primary	Comparison of Quantra Clot Time and Clot Stiffness results to comparable ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, during surgery, and up to 24 hours post-surgery