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NCT05376462 Clinical Trial

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: Active, not recruiting

Administrative data
NCT number NCT05376462
Other study ID # HEMCS-039
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 12, 2022
Est. completion date April 1, 2024

Study information
Verified date February 2024
Source HemoSonics LLC
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 36
Est. completion date April 1, 2024
Est. primary completion date March 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.

Study Design

Related Conditions & MeSH terms

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
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