Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

This study has been completed.
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01408823
First received: July 13, 2011
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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.


Condition
Scoliosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pharmacokinetics of Epsilon-Aminocaproic Acid in Children and Adolescents With Scoliosis Undergoing Posterior Spinal Fusion

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion [ Time Frame: up to 15 hours ] [ Designated as safety issue: No ]
    The primary endpoint is the clearance of EACA


Secondary Outcome Measures:
  • Determine population-specific EACA dosing strategies based on the observed EACA pharmacokinetics [ Time Frame: one year ] [ Designated as safety issue: No ]
    Population-specific EACA dosing strategies for patients with non-idiopathic and idiopathic scoliosis

  • Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion [ Time Frame: up to 15 hours ] [ Designated as safety issue: No ]
    A secondary endpoint is the calculation of mean concentration levels of EACA in the body (AUC0-∞)

  • Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion [ Time Frame: up to 15 hours ] [ Designated as safety issue: No ]
    A secondary endpoint is the clearance of EACA

  • Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion [ Time Frame: up to 15 hours ] [ Designated as safety issue: No ]
    A secondary endpoint is the half-life of EACA

  • Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion [ Time Frame: up to 15 hours ] [ Designated as safety issue: No ]
    A secondary endpoint is the volume of distribution of EACA


Enrollment: 20
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Idiopathic Scoliosis
Non-idiopathic Scoliosis

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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408823

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Investigators
Principal Investigator: Paul Stricker, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01408823     History of Changes
Other Study ID Numbers: 11-008205
Study First Received: July 13, 2011
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Pediatrics
Scoliosis
Pharmacokinetics
Hemorrhage
Orthopedic Surgery

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014