Quantra® System With the QStat® Cartridge in Trauma

HemoSonics

Status: Terminated

Conditions: Coagulation Defect; Bleeding; Trauma

Treatments: Diagnostic Test: Quantra System with the QStat Cartridge

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05376462

HEMCS-039

Details and patient eligibility

About

This is a prospective, single-center, observational study to assess the Quantra QStat System in trauma patients.

Full description

This is a prospective, single-center, observational study to assess the performance of the Quantra QStat System in trauma patients.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

36 participants in 1 patient group

Quantra System with the QStat Cartridge

Description:

Viscoelastic testing using the Quantra System with the QStat Cartridge.

Treatment:

Diagnostic Test: Quantra System with the QStat Cartridge