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 determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.
The hemostatic profile of an infant is different than that of an adult and changes with age. Most differences occur within the first 6 months of age, with coagulation function similar to that of an adult within the first year of life. To assess the clinical utility of the Quantra System in pediatric patients that are bleeding or at risk for bleeding, it is important to understand the normal reference intervals for the parameters reported by the QPlus Cartridge in normal, healthy pediatric patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients |
|
| 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 |
|---|---|---|
| Reference range intervals for measurement of Clot Time (CT) parameter | Reference range intervals for CT in pediatric patients | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameter | Reference range intervals for CTH in pediatric patients | Baseline, determined from a single blood draw. |
| Reference range intervals for measurement of Clot Stiffness (CS) parameter | Reference range intervals for CS in pediatric patients | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter | Reference range intervals for FCS in pediatric patients | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Platelet Contribution (PCS) parameter | Reference range intervals for PCS in pediatric patients | Baseline, determined from a single blood draw |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Children, age birth to <18 years of age, scheduled for a procedure requiring anesthesia in which vascular access would routinely be placed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Winegar, PhD | Contact | 19192446990 | dwinegar@hemosonics.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Mattel Children's Hospital | Los Angeles | California | 90095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
|
| University Children's Hospital Zurich | Zurich | 8008 | Switzerland |
|