Quantra® System With the QStat® Cartridge in Trauma

March 11, 2025 updated by: HemoSonics LLC

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord Pas De Calais
      • Lille, Nord Pas De Calais, France, 59037
        • Hopital Universitaire de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Trauma patients requiring a full trauma team response.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Quantra System with the QStat Cartridge
Viscoelastic testing using the Quantra System with the QStat Cartridge.
Diagnostic test: Quantra System with the QStat Cartridge
Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total units of red blood cells (RBC) transfused
Time Frame: 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.
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
Time Frame: 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.
48 hours after admission to the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HemoSonics LLC

Collaborators

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2022

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMCS-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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