Quantra® System With the QStat® Cartridge in Trauma

Sponsor

HemoSonics LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05376462

Collaborator

University Hospital, Lille (Other)

154

Enrollment

Location

Arms

17.6

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Coagulation Defect; Bleeding	Diagnostic Test: Quantra System with the QStat Cartridge Diagnostic Test: Standard Laboratory Tests	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

One group of trauma patients will receive blood products based on information provided by the Quantra with the QStat Cartridge. The second group will receive blood products based on information provided by standard laboratory coagulation tests.One group of trauma patients will receive blood products based on information provided by the Quantra with the QStat Cartridge. The second group will receive blood products based on information provided by standard laboratory coagulation tests.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 12, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Diagnostic Test: Quantra System with the QStat Cartridge Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status.
Active Comparator: Standard Laboratory Coagulation Testing 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.	Diagnostic Test: Standard Laboratory Tests Laboratory tests that provide information about a patient's coagulation status.

Arm

Intervention/Treatment

Experimental: 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.

Diagnostic Test: Quantra System with the QStat Cartridge

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

Active Comparator: Standard Laboratory Coagulation Testing

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.

Diagnostic Test: Standard Laboratory Tests

Laboratory tests that provide information about a patient's coagulation status.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Universitaire de Lille	Lille	Nord Pas De Calais	France	59037

Sponsors and Collaborators

HemoSonics LLC
University Hospital, Lille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HemoSonics LLC

ClinicalTrials.gov Identifier:

NCT05376462

Other Study ID Numbers:

HEMCS-039

First Posted:

May 17, 2022

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by HemoSonics LLC

Quantra

QStat

Viscoelastic testing

Additional relevant MeSH terms:

Hemostatic Disorders

Blood Coagulation Disorders

Wounds and Injuries

Study Results

No Results Posted as of May 24, 2022