QStat in Liver Transplant

NCT ID: NCT04114253

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-04

Study Completion Date

2020-12-12

Brief Summary

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This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.

Detailed Description

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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 propoerties of a whole blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects.

This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.

Conditions

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Blood Loss, Surgical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver transplant patients

Adult patients undergoing deceased donor liver transplantation.

Quantra System

Intervention Type DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Interventions

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Quantra System

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Quantra QStat Cartridge

Eligibility Criteria

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Inclusion Criteria

* Subject is ≥ 18 years of age
* Subject is undergoing deceased donor liver transplant and is a candidate for a TEG test to be performed to access coagulopathy during surgery.
* Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

Exclusion Criteria

* Subject is younger than 18 years of age
* Subject is known to have received antifibrinolytic therapy immediately prior to the start of liver transplantation surgery.
* Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HemoSonics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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HEMCS-029

Identifier Type: -

Identifier Source: org_study_id

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