Exploratory Assessment of the Quantra® System in Adult ECMO Patients
1 other identifier
observational
10
1 country
1
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 life support (ECLS) procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedStudy Start
First participant enrolled
September 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 15, 2023
June 1, 2023
8 months
June 7, 2022
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Comparison of Quantra Clot Time results to standard coagulation test results.
Coagulation function assessed by Quantra and standard-of-care coagulation tests
At the start of ECMO (considered the Baseline timepoint)
Comparison of Quantra Clot Stiffness results to standard coagulation test results.
Coagulation function assessed by Quantra and standard-of-care coagulation tests
At the start of ECMO (considered the Baseline timepoint)
Comparison of Quantra Clot Time results to standard coagulation test results.
Coagulation function assessed by Quantra and standard-of-care coagulation tests
6 hours after the previous measurment
Comparison of Quantra Clot Stiffness results to standard coagulation test results.
Coagulation function assessed by Quantra and standard-of-care coagulation tests
6 hours after the previous measurment
Study Arms (1)
ECMO Patients
Patients undergoing an ECMO procedure
Interventions
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Eligibility Criteria
Patients undergoing arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure. Both COVID-19 and non-COVID-19 related ECMO patients will be enrolled
You may qualify if:
- 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 may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HemoSonics LLClead
- University of California, Irvinecollaborator
Study Sites (1)
University of California Irvine
Irvine, California, 92697, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 22, 2022
Study Start
September 27, 2022
Primary Completion
May 17, 2023
Study Completion
June 1, 2023
Last Updated
June 15, 2023
Record last verified: 2023-06