Evaluation of the Quantra System in a Surgical Oncological Population

Blood Loss, Surgical Clinical Trial

Official title:

Evaluation of the Quantra System in a Surgical Oncological Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04116385
• Other study ID #: HEMCS-025
• Status: Completed
• Start date: August 15, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2020
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 QPlus 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 iin parallel yielding six parameters that depict the functional status of a patient's coagulation system.

The oncologic surgical population presents unique challenges to providers who must distinguish between a cancer patient's increased tendency toward both thrombosis and hemorrhage. This single site prospective observational study in oncologic patients will give an insight into the coagulation status of critically ill cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 30, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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 Texas MD Anderson Cancer Center	Houston	Texas

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 results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	Baseline, defined as after induction of anesthesia, before surgical incision
Primary	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
Primary	Comparison of Quantra Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	During surgery
Primary	Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	During surgery
Primary	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
Primary	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