Status:
TERMINATED
Quantra® System With the QStat® Cartridge in Trauma
Lead Sponsor:
HemoSonics LLC
Collaborating Sponsors:
University Hospital, Lille
Conditions:
Trauma
Coagulation Defect; Bleeding
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
April 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05376462
Start Date
April 12 2022
End Date
January 1 2024
Last Update
March 14 2025
Active Locations (1)
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1
Hopital Universitaire de Lille
Lille, Hauts-de-France, France, 59037