Quantra QStat in Trauma and Liver Transplant

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

397 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-20

Study Completion Date

2023-04-13

Brief Summary

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

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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 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.

Conditions

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Hemorrhage Trauma Liver Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trauma patients

Trauma patients experiencing traumatic injuries requiring a full trauma team response.

Quantra System

Intervention Type DIAGNOSTIC_TEST

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

Liver transplant patients

Patients undergoing liver transplant surgery.

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
* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No