Quantra® System With the QStat® Cartridge in Trauma

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05376462

Enrollment

Registered

2022-05-17

Start date

2022-04-12

Completion date

2024-01-01

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Defect; Bleeding, Trauma

Keywords

Quantra, QStat, Viscoelastic testing

Brief summary

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

Detailed description

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

Interventions

DIAGNOSTIC_TESTQuantra System with the QStat Cartridge

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Total units of red blood cells (RBC) transfused	24 hours post-presentation for trauma subjects	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.

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026