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This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
Pediatric patients that require major sugical procedures, such as cardiac surgery, are especially vulnerable to perioperative coagulopathy due to age-related immaturity of the hemostatic system, exposure to hemodilution from circuit primes or intravenous volume loading, hypothermia during complex interventions, and the intrinsic bleeding of invasive cardiac procedures. These factors can produce clinically significant perioperative bleeding driven by platelet dysfunction, hypofibrinogenemia and other hemostatic defects. The Quantra System with the QPlus Cartridge is desinged to assess coagulation function of a whole blood sample at the point-of-care by measuring changes in the viscoelastic properties during clot formation. This multi-center study is aimed to demonstrate the performance of the QPlus Cartridge for its ability to aid in the evaluation of a pediatric patient's hemostatic status before, during and after cardiovascular procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients | Pediatric patients undergoing cardiovascular procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra System | Diagnostic Test | Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT | Coagulation function assessed by Quantra and ROTEM sigma | 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure. |
| Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT | Coagulation function assessed by Quantra and ROTEM sigma | 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure. |
| Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10 | Coagulation function assessed by Quantra and ROTEM sigma | 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure. |
| Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10 | Coagulation function assessed by Quantra and ROTEM sigma | 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure. |
| Correlation of QPlus CT to TEG 6S CK-R | Coagulation function assessed by Quantra and TEG 6S | 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure. |
| Correlation of QPlus CTH to TEG 6S CKH-R | Coagulation function assessed by Quantra and TEG 6S | 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes pediatric patients <18 years of age that are undergoing cardiovascular procedures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Winegar | Contact | 9192446990 | dwinegar@hemosonics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Mattel Children's Hospital | Los Angeles | California | 90095 | United States | ||
| Children's Healthcare of Atlanta |
Data sharing agreements prevent sharing of IPD.
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| Correlation of QPlus CS to TEG 6S CKH-MA | Coagulation function assessed by Quantra and TEG 6S | 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure. |
| Correlation of QPlus FCS to TEG 6S FFH-MA | Coagulation function assessed by Quantra and TEG 6S | 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure. |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |