Back to resultsQuantra® System With the QStat® Cartridge in Trauma
Primary Purpose
Trauma, Coagulation Defect; Bleeding
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quantra System with the QStat Cartridge
Standard Laboratory Tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Trauma focused on measuring Quantra, QStat, Viscoelastic testing
Eligibility Criteria
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.
Sites / Locations
- Hopital Universitaire de Lille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quantra System with the QStat Cartridge
Standard Laboratory Coagulation Testing
Arm Description
Decisions regarding transfusion of blood products will be made based on information derived from the Quantra System with the QStat Cartridge.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05376462
First Posted
May 11, 2022
Last Updated
September 21, 2023
Sponsor
HemoSonics LLC
Collaborators
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT05376462
Brief Title
Quantra® System With the QStat® Cartridge in Trauma
Official Title
An Interventional Randomized Controlled Trial of the Quantra® System With the QStat® Cartridge in Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HemoSonics LLC
Collaborators
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Coagulation Defect; Bleeding
Keywords
Quantra, QStat, Viscoelastic testing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quantra System with the QStat Cartridge
Arm Type
Experimental
Arm Description
Decisions regarding transfusion of blood products will be made based on information derived from the Quantra System with the QStat Cartridge.
Arm Title
Standard Laboratory Coagulation Testing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantra System with the QStat Cartridge
Intervention Description
Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard Laboratory Tests
Intervention Description
Laboratory tests that provide information about a patient's coagulation status.
Primary Outcome Measure Information:
Title
Total units of red blood cells (RBC) transfused
Description
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.
Time Frame
24 hours post-presentation for trauma subjects
Secondary Outcome Measure Information:
Title
Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA transfused
Description
Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA administered within at 48 hrs after admission to the hospital.
Time Frame
48 hours after admission to the hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hopital Universitaire de Lille
City
Lille
State/Province
Nord Pas De Calais
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Learn more about this trial
Quantra® System With the QStat® Cartridge in Trauma
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