Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacokinetics of Epsilon-Aminocaproic Acid in Children and Adolescents With Scoliosis Undergoing Posterior Spinal Fusion

Conditions
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Scoliosis

Participation Criteria
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Eligibility Criteria
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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. - Exclusion Criteria: Wards of the State are not eligible Subjects with a history of abnormal renal function -

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic Scoliosis<br> | |
| Non-idiopathic Scoliosis<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Scoliosis, Pharmacokinetics, Hemorrhage, Orthopedic Surgery