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PI relocated to another institution
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Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals.
Single center observational study of the pediatric patient population (< 18yrs) with normal coagulation function to determine the reference range interval for the clotting parameters reported by the Quantra QPlus system.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test | Device | Diagnostic device to monitor coagulation properties of a whole blood sample at the point of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reference range interval for measurement of clot time (CT) parameter | Reference range interval determined in this study will serve as the reference for CT results in this particular population | Baseline, after access placement before any procedures |
| Reference range interval for measurement of clot time (CTH) parameter | Reference range interval determined in this study will serve as the reference for CTH results in this particular population | Baseline, after access placement before any procedures |
| Reference range interval for measurement of clot stiffness (CS) parameter | Reference range interval determined in this study will serve as the reference for CS results in this particular population | Baseline, after access placement before any procedures |
| Reference range interval for measurement of Fibrinogen Contribution to clot stiffness (FCS) parameter | Reference range interval determined in this study will serve as the reference for FCS results in this particular population | Baseline, after access placement before any procedures |
| Reference range interval for measurement of Platelet Contribution to clot stiffness (PCS) parameter | Reference range interval determined in this study will serve as the reference for PCS results in this particular population | Baseline, after access placement before any procedures |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients with normal coagulation function who have been scheduled to undergo a procedure and blood sampling access has been established. All genders, racial and ethnic profiles will be described.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Tirotta, MD | Nicklaus Childrens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicklaus Childrens Hospital | Miami | Florida | 33155 | United States |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003955 | Diagnostic Tests, Routine |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |