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

NCT03152461 | Completed FDA Device

• 1 other identifier: HEMCS-008
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 4

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).

Conditions

Blood Loss, Surgical

Keywords

Viscoelastic testing; Coagulation; Quantra; Hemostasis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

Quantra System DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Also known as: Quantra Surgical Cartridge

Surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (4)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27703, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Thrombosis

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 15, 2017
• Study Start: May 23, 2017
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)