Status:
COMPLETED
Evaluation of the Quantra System in a Surgical Oncological Population
Lead Sponsor:
HemoSonics LLC
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
18+ years
Brief Summary
This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04116385
Start Date
August 15 2019
End Date
July 30 2020
Last Update
September 1 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030