Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.

Official Title

Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation

Details

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 QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system. This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.

Keywords

Hemorrhage Trauma Liver Transplant Viscoelastic testing Coagulation Quantra QStat Wounds and Injuries Quantra System

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subject is > 18 years
  • Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
  • Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent.

You CAN'T join if...

  • Subject is younger than 18 years of age
  • Subject is pregnant.
  • Subject is incarcerated at the time of the study.
  • Subject is currently enrolled in a distinct 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.

Locations

  • Zuckerberg San Francisco General Hospital and Trauma Center
    San Francisco California 94110 United States
  • University of Michigan Medical Center
    Ann Arbor Michigan 98109 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
HemoSonics LLC
ID
NCT04312958
Study Type
Observational
Last Updated