This study is accepting new patients by invitation only

Exploratory Assessment of the Quantra® System in Adult ECMO Patients

a study on Blood Loss Thrombosis Extracorporeal Circulation

Summary

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

Description

Summary

This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.

Official Title

Exploratory Assessment of the Quantra® System With the QPlus® and QStat® Cartridges in Adult ECMO Patients

Details

Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.

Keywords

Blood Loss, Thrombosis, Extracorporeal Circulation; Complications, Quantra, ECMO, QPlus, Viscoelastic testing, Coagulation, Quantra System

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subject is > 18 years.
  • Subject is scheduled to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours.
  • Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred 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, or subject's legally authorized representative is unable or unwilling to provide informed consent.
  • Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.

Location

  • University of California Irvine
    Irvine California 92697 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
HemoSonics LLC
ID
NCT05426564
Study Type
Observational
Participants
Expecting 30 study participants
Last Updated