Clinical trial NCT01408823: Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery
Official title: Pharmacokinetics of Epsilon-Aminocaproic Acid in Children and Adolescents With Scoliosis Undergoing Posterior Spinal Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: Pediatrics
Scoliosis
Pharmacokinetics
Hemorrhage
Orthopedic Surgery
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Children's Anesthesiology Associates, Ltd.
First posted: 2011-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and Adolescents scheduled to have posterior spinal fusion surgery at The Children's Hospital of Philadelphia

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.

Eligibility 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.

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Exclusion Criteria:

1. Wards of the State are not eligible
2. Subjects with a history of abnormal renal function -

Primary outcomes:
measure: Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
timeFrame: up to 15 hours
Secondary outcomes:
measure: Determine population-specific EACA dosing strategies based on the observed EACA pharmacokinetics
timeFrame: one year
measure: Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
timeFrame: up to 15 hours
measure: Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
timeFrame: up to 15 hours
measure: Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
timeFrame: up to 15 hours
measure: Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
timeFrame: up to 15 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Paul Stricker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stricker PA, Gastonguay MR, Singh D, Fiadjoe JE, Sussman EM, Pruitt EY, Goebel TK, Zuppa AF. Population pharmacokinetics of ϵ-aminocaproic acid in adolescents undergoing posterior spinal fusion surgery. Br J Anaesth. 2015 Apr;114(4):689-99. doi: 10.1093/bja/aeu459. Epub 2015 Jan 13.