Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408823
• Other study ID #: 11-008205
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: August 7, 2013
• Start date: July 2011
• Est. completion date: October 2011

Study information

• Verified date: August 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Children's Anesthesiology Associates, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion	The primary endpoint is the clearance of EACA	up to 15 hours	No
Secondary	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	No
Secondary	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 (AUC0-8)	up to 15 hours	No
Secondary	Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion	A secondary endpoint is the clearance of EACA	up to 15 hours	No
Secondary	Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion	A secondary endpoint is the half-life of EACA	up to 15 hours	No
Secondary	Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion	A secondary endpoint is the volume of distribution of EACA	up to 15 hours	No