Quantra® System With the QStat® Cartridge in Trauma

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376462
• Other study ID #: HEMCS-039
• Status: Completed
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2024
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single-center, controlled, open label, trial randomized in two parallel groups designed to assess the Quantra QStat System in trauma patients.

Description:

This is a prospective, single-center, controlled, open label, trial randomized in two parallel groups designed to assess the Quantra QStat System in trauma patients. A Phase I observational study will precede an interventional Phase II study randomized in 2 arms with in which one group of patients will be treated based on information provided by the Quantra (with the QStat Cartridge) and the other group using the standard laboratory tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Defect; Bleeding
• Hemostatic Disorders
• Trauma
• Wounds and Injuries

Intervention

Diagnostic Test:
• Quantra System with the QStat Cartridge
Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status.
• Standard Laboratory Tests
Laboratory tests that provide information about a patient's coagulation status.

Locations

Country	Name	City	State
France	Hopital Universitaire de Lille	Lille	Nord Pas De Calais

Sponsors (2)

Lead Sponsor	Collaborator
HemoSonics LLC	University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA transfused	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