Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

Completed

• Conditions: Scoliosis

• Registration Number: NCT01408823
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion	up to 15 hours	The primary endpoint is the clearance of EACA

Secondary Outcome Measures

Name	Time	Method
Determine population-specific EACA dosing strategies based on the observed EACA pharmacokinetics	one year	Population-specific EACA dosing strategies for patients with non-idiopathic and idiopathic scoliosis
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion	up to 15 hours	A secondary endpoint is the volume of distribution of EACA

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States