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| Name | Class |
|---|---|
| Children's Anesthesiology Associates, Ltd. | OTHER |
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This study will evaluate the pharmacokinetics of antifibrinolytic drug epsilon-aminocaproic acid (EACA) in children undergoing Posterior spinal fusion surgery (PSF) at The Children's Hospital of Philadelphia (CHOP) who receive EACA at the standard dose reported in the literature for this population and currently in use at CHOP.
Posterior spinal fusion surgery (PSF) can be associated with significant blood loss, and perioperative transfusion is common. Various strategies have been employed to decrease intraoperative blood loss and reduce transfusion in children undergoing PSF. The intraoperative administration of the antifibrinolytic drug epsilon-aminocaproic acid (EACA) is one such strategy that has been shown to be effective in this regard. This study will evaluate the pharmacokinetics of EACA in children undergoing PSF at CHOP who receive EACA at the standard dose reported in the literature for this population and currently in use at CHOP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic Scoliosis | |||
| Non-idiopathic Scoliosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion | The primary endpoint is the clearance of EACA | up to 15 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Determine population-specific EACA dosing strategies based on the observed EACA pharmacokinetics | Population-specific EACA dosing strategies for patients with non-idiopathic and idiopathic scoliosis | one year |
| Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion |
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Inclusion Criteria:
1)Males or females age 8 to 18 years 2)Subjects undergoing posterior spinal fusion surgery 3)Subjects in whom aminocaproic acid administration is planned by the anesthesiology team 4)Parental/guardian permission (written informed consent) and when appropriate, child assent.
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Exclusion Criteria:
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Children and Adolescents scheduled to have posterior spinal fusion surgery at The Children's Hospital of Philadelphia
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| Name | Affiliation | Role |
|---|---|---|
| Paul Stricker, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25586726 | Derived | Stricker PA, Gastonguay MR, Singh D, Fiadjoe JE, Sussman EM, Pruitt EY, Goebel TK, Zuppa AF. Population pharmacokinetics of ϵ-aminocaproic acid in adolescents undergoing posterior spinal fusion surgery. Br J Anaesth. 2015 Apr;114(4):689-99. doi: 10.1093/bja/aeu459. Epub 2015 Jan 13. |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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A secondary endpoint is the calculation of mean concentration levels of EACA in the body (AUC0-∞) |
| up to 15 hours |
| Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion | A secondary endpoint is the clearance of EACA | up to 15 hours |
| Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion | A secondary endpoint is the half-life of EACA | up to 15 hours |
| Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion | A secondary endpoint is the volume of distribution of EACA | up to 15 hours |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |