Status:
COMPLETED
Exploratory Assessment of the Quantra® System in Adult ECMO Patients
Lead Sponsor:
HemoSonics LLC
Collaborating Sponsors:
University of California, Irvine
Conditions:
Blood Loss
Thrombosis
Eligibility:
All Genders
18+ years
Brief 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 l...
Detailed Description
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 explor...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05426564
Start Date
September 27 2022
End Date
June 1 2023
Last Update
June 15 2023
Active Locations (1)
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1
University of California Irvine
Irvine, California, United States, 92697