Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.
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 tobstetric hemorrhage population. 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 multicenter, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard of care coagulation testing in pregnant women at risk of bleeding at delivery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obstetric Patients | Obstetric patient population at risk of experiencing excessive bleeding around the time of delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra Hemostasis Analyzer with the QStat Cartridge | 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 to laboratory aPTT test results | Coagulation function assessed by Quantra Clot Time (CT, sec) and activated partial thromboplastin (aPTT, sec) test | At the time hemorrhage is suspected, anticipated within 24 hours after birth |
| Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results | Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and Clauss fibrinogen (mg/dL) test | At the time hemorrhage is suspected, anticipated within 24 hours after birth |
| Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results | Coagulation function assessed by Quantra Clot Time (CT, sec) and ROTEM INTEM CT (sec) test | At the time hemorrhage is suspected, anticipated within 24 hours after birth |
| Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to ROTEM delta FIBTEM test results | Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and ROTEM FIBTEM (mm) test | At the time hemorrhage is suspected, anticipated within 24 hours after birth |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant females
Parturients 18 years or older who are at risk of experiencing an obstetric hemorrhage around the time of delivery.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States | ||
| Ohio State University Wexner Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Parkland Health | Dallas | Texas | 75235 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |