Evaluation of the Quantra System in a Surgical Oncological Population

NCT04116385 | Completed FDA Device

• 1 other identifier: HEMCS-025
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.

Conditions

Blood Loss, Surgical

Keywords

Viscoelastic testing; Coagulation; Quantra; Hemostasis

Outcome Measures

Primary Outcomes (6)

• Comparison of Quantra Clot Time results to TEG R results

  Coagulation function assessed by Quantra and TEG 5000

  Baseline, defined as after induction of anesthesia, before surgical incision

• Comparison of Quantra Clot Stiffness results to TEG MA results

  Coagulation function assessed by Quantra and TEG 5000

  Baseline, defined as after induction of anesthesia, before surgical incision

• Comparison of Quantra Time results to TEG R results

  Coagulation function assessed by Quantra and TEG 5000

  During surgery

• Comparison of Quantra Clot Stiffness results to TEG MA results

  Coagulation function assessed by Quantra and TEG 5000

  During surgery

• Comparison of Quantra Clot Time results to TEG R results

  Coagulation function assessed by Quantra and TEG 5000

  Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery

• Comparison of Quantra Clot Stiffness results to TEG MA results

  Coagulation function assessed by Quantra and TEG 5000

  Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery

Study Arms (1)

Cancer surgery patients

Adult subjects (18 years or older) undergoing an oncologic surgical procedure.

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 QPlus System

Cancer surgery 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 adult subjects undergoing an oncologic surgical procedure.

You may qualify if:

• Subject is \>= 18 years
• Subject is diagnosed with cancer and is scheduled for surgical resection
• Subject is willing to participate, and he/she or a Legally Authorized Representative (LAR) has signed a consent form
• Surgical procedure to be performed has an anticipated blood loss (\>500mL) based on historical data

You may not qualify if:

• Subject is younger than 18 years
• Subject or a subject's LAR is unable to provide written informed consent
• Subject is undergoing an emergent procedure.
• Subject is pregnant, has active liver disease, or severe renal dysfunction (creatinine clearance (CrCL)\<30 mL/min)
• Subject has an extremely low platelet count (\<40,000/uL)
• Subject is currently enrolled in a distinct study that might confound the results of the proposed study
• Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, 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: October 1, 2019
• First Posted: October 4, 2019
• Study Start: August 15, 2019
• Primary Completion: March 12, 2020
• Study Completion: July 30, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)