Quantra® System With the QStat® Cartridge in Trauma

Study Overview
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Brief Summary
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This is a prospective, single-center, controlled, open label, trial randomized in two parallel groups designed to assess the Quantra QStat System in trauma patients.

Detailed Description
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This is a prospective, single-center, controlled, open label, trial randomized in two parallel groups designed to assess the Quantra QStat System in trauma patients. A Phase I observational study will precede an interventional Phase II study randomized in 2 arms with in which one group of patients will be treated based on information provided by the Quantra (with the QStat Cartridge) and the other group using the standard laboratory tests.

Official Title
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An Interventional Randomized Controlled Trial of the Quantra® System With the QStat® Cartridge in Trauma

Conditions
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Trauma, Coagulation Defect; Bleeding

Intervention / Treatment
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* Diagnostic Test: Quantra System with the QStat Cartridge
* Diagnostic Test: Standard Laboratory Tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is > 18 years; Children under the age of 18 are protected by adults under guardianship or by court order. Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response according to site's level 1of trauma team activation criteria. Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent. Exclusion Criteria Subject is pregnant. Subject is currently enrolled in a distinct study that might confound the result of the proposed study. Subject is not covered by social security.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: One group of trauma patients will receive blood products based on information provided by the Quantra with the QStat Cartridge. The second group will receive blood products based on information provided by standard laboratory coagulation tests.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quantra System with the QStat Cartridge<br>Decisions regarding transfusion of blood products will be made based on information derived from the Quantra System with the QStat Cartridge. | Diagnostic Test: Quantra System with the QStat Cartridge<br>* Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status.<br>|
| Active Comparator: Standard Laboratory Coagulation Testing<br>Decisions regarding transfusion of blood products will be made based on the site's standard of care which is information derived from standard laboratory coagulation tests. | Diagnostic Test: Standard Laboratory Tests<br>* Laboratory tests that provide information about a patient's coagulation status.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total units of red blood cells (RBC) transfused | The primary endpoint of Phase II will be the total units of red blood cells (RBC) transfused and administered 24 hours post-presentation for trauma subjects. | 24 hours post-presentation for trauma subjects | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA transfused | Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA administered within at 48 hrs after admission to the hospital. | 48 hours after admission to the hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quantra, QStat, Viscoelastic testing