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Completed

NCT Number: NCT01408823

Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

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.

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Key information

Conditions

Scoliosis Bone Diseases Hemorrhage Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Curvatures Spinal Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Exclusion criteria

  • Wards of the State are not eligible
  • Subjects with a history of abnormal renal function -

Treatment and study plan

Primary outcomes

  1. Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion

    Time frame: up to 15 hours

    The primary endpoint is the clearance of EACA

Secondary outcomes

  1. 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

  2. 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-∞)

  3. Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion

    Time frame: up to 15 hours

    A secondary endpoint is the clearance of EACA

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Children's Anesthesiology Associates, Ltd.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 3, 2011
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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