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This pilot study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in bleeding pregnant women 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 single-center, 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 bleeding pregnant women at delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obstetric Patients | Obstetric patient population experiencing excessive bleeding around the time of delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra System | Device | 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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 24 hours after birth |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant females
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Pparturients 18 years or older who experience an obstetric hemorrhage around the time of delivery or cumulatively over 24h after delivery or unstable vital signs or clinical signs of a coagulopathy managed with activation of the stage 2 OB hemorrhage protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |