Quantra® System With the QStat® Cartridge in Trauma

Not Applicable

Terminated

• Conditions: Coagulation Defect; Bleeding; Trauma
• Interventions: Diagnostic Test: Quantra System with the QStat Cartridge; Diagnostic Test: Standard Laboratory Tests

• Registration Number: NCT05376462
• Lead Sponsor: HemoSonics LLC

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.

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Quantra System with the QStat Cartridge	Quantra System with the QStat Cartridge	Decisions regarding transfusion of blood products will be made based on information derived from the Quantra System with the QStat Cartridge.
Standard Laboratory Coagulation Testing	Standard Laboratory Tests	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hopital Universitaire de Lille; 🇫🇷 Lille, Nord Pas De Calais, France