Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

August 7, 2013 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and Adolescents scheduled to have posterior spinal fusion surgery at The Children's Hospital of Philadelphia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Idiopathic Scoliosis
Non-idiopathic Scoliosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
Time Frame: up to 15 hours
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
Time Frame: one year
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
Time Frame: up to 15 hours
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
Time Frame: up to 15 hours
A secondary endpoint is the clearance of EACA
up to 15 hours
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
Time Frame: up to 15 hours
A secondary endpoint is the half-life of EACA
up to 15 hours
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
Time Frame: up to 15 hours
A secondary endpoint is the volume of distribution of EACA
up to 15 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Children's Anesthesiology Associates, Ltd.

Investigators

  • Principal Investigator: Paul Stricker, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 7, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-008205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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