Quantra® System With the QStat® Cartridge in Trauma

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

TERMINATED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-12

Study Completion Date

2024-01-01

Brief Summary

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This is a prospective, single-center, observational study to assess the Quantra QStat System in trauma patients.

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Detailed Description

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This is a prospective, single-center, observational study to assess the performance of the Quantra QStat System in trauma patients.

Conditions

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Trauma Coagulation Defect; Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Quantra System with the QStat Cartridge

Viscoelastic testing using the Quantra System with the QStat Cartridge.

Quantra System with the QStat Cartridge

Intervention Type DIAGNOSTIC_TEST

Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status.

Interventions

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Quantra System with the QStat Cartridge

Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status.

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No