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Only Phase 1 (observational) completed. Did not proceed to Phase 2 due to site time constraints/competing priorities.
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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
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This is a prospective, single-center, observational study to assess the Quantra QStat System in trauma patients.
This is a prospective, single-center, observational study to assess the performance of the Quantra QStat System in trauma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quantra System with the QStat Cartridge | Viscoelastic testing using the Quantra System with the QStat Cartridge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra System with the QStat Cartridge | Diagnostic Test | Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria
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Trauma patients requiring a full trauma team response.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Universitaire de Lille | Lille | Hauts-de-France | 59037 | France |
No plan to share individual data.
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |