Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

Children's Hospital of Philadelphia20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Scoliosis

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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: 1. Wards of the State are not eligible 2. Subjects with a history of abnormal renal function -

Locations (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion

The primary endpoint is the clearance of EACA

Time frame: up to 15 hours

Secondary Outcomes

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

Time frame: 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-∞)

Time frame: up to 15 hours

Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion

A secondary endpoint is the clearance of EACA

Time frame: up to 15 hours

Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion

A secondary endpoint is the half-life of EACA

Time frame: up to 15 hours

Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion

A secondary endpoint is the volume of distribution of EACA

Time frame: up to 15 hours

Data from ClinicalTrials.gov

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