Evaluation of the Quantra System in a Surgical Oncological Population

Completed

Conditions studied: Blood Loss, Surgical

In brief

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

Key facts

Study ID

NCT04116385

Run by

HemoSonics LLC

People needed

75

Starts

2019-08-15

Expected to finish

2020-07-30

Last updated by the study team

2020-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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