Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01408823

Enrollment

Registered

2011-08-03

Start date

2011-07-31

Completion date

2011-10-31

Last updated

2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Pediatrics, Scoliosis, Pharmacokinetics, Hemorrhage, Orthopedic Surgery

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

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 -

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 calculation of mean concentration levels of EACA in the body (AUC0-∞)

Countries

United States

Outcome results