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This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.
This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma patients | Trauma patients experiencing traumatic injuries requiring a full trauma team response. |
| |
| Liver transplant patients | Patients undergoing liver transplant surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra System | Diagnostic Test | Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results | Coagulation function assessed by Quantra and ROTEM Delta | Upon arrival of trauma subject to the emergency department |
| Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, immediately before the start of liver transplant surgery |
| Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results | Coagulation function assessed by Quantra and ROTEM Delta | During anhepatic phase of liver transplant surgery |
| Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results | Coagulation function assessed by Quantra and ROTEM Delta | During post-reperfusion phase of liver transplant surgery |
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | Upon arrival of trauma subject to the emergency department |
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, immediately before the start of liver transplant surgery |
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results |
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Inclusion Criteria:
Exclusion Criteria:
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Potential study participants will be adult (>18 years) trauma patients or patients undergoing liver transplant surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California | 94110 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40486089 | Derived | Moore EE, Michelson EA, Gabriel-Ramos K, Cripps MW, Flores A, Vandyck K, Thurston B, Brennan M, Viola F, Winegar DA. Multicenter evaluation of the Quantra with the QStat Cartridge in adult trauma patients. Trauma Surg Acute Care Open. 2025 Jun 3;10(2):e001672. doi: 10.1136/tsaco-2024-001672. eCollection 2025. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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|
Coagulation function assessed by Quantra and ROTEM Delta
| During anhepatic phase of liver transplant surgery |
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | During post-reperfusion phase of liver transplant surgery |
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | Upon arrival of trauma subject to the emergency department |
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, immediately before the start of liver transplant surgery |
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | During anhepatic phase of liver transplant surgery |
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | During post-reperfusion phase of liver transplant surgery |
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Coagulation function assessed by Quantra and ROTEM Delta | Upon arrival of trauma subject to the emergency department |
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, immediately before the start of liver transplant surgery |
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Coagulation function assessed by Quantra and ROTEM Delta | During anhepatic phase of liver transplant surgery |
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Coagulation function assessed by Quantra and ROTEM Delta | During post-reperfusion phase of liver transplant surgery |
| University of Colorado |
| Denver |
| Colorado |
| 28037 |
| United States |
| University of Florida Health Shands Hospital | Gainesville | Florida | 32608 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 98109 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | United States |
| D002318 | Cardiovascular Diseases |