Quantra® System With the QStat® Cartridge in Trauma

NCT05376462 | Terminated FDA Device

• 1 other identifier: HEMCS-039
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trauma; Coagulation Defect; Bleeding

Keywords

Quantra; QStat; Viscoelastic testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA transfused

  48 hours after admission to the hospital

Study Arms (1)

Quantra System with the QStat Cartridge

Viscoelastic testing using the Quantra System with the QStat Cartridge.

Diagnostic Test: Quantra System with the QStat Cartridge

Interventions

Quantra System with the QStat Cartridge DIAGNOSTIC_TEST

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

Quantra System with the QStat Cartridge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Trauma patients requiring a full trauma team response.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HemoSonics LLC: lead
• University Hospital, Lille: collaborator

Study Sites (1)

Hopital Universitaire de Lille

Lille, Hauts-de-France, 59037, France

Location

MeSH Terms

Conditions

Wounds and Injuries; Hemostatic Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: April 12, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)