Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery
Pharmacokinetics of Epsilon-Aminocaproic Acid in Children and Adolescents With Scoliosis Undergoing Posterior Spinal Fusion
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
August 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedAugust 9, 2013
August 1, 2013
3 months
July 13, 2011
August 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
The primary endpoint is the clearance of EACA
up to 15 hours
Secondary Outcomes (5)
Determine population-specific EACA dosing strategies based on the observed EACA pharmacokinetics
one year
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
up to 15 hours
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
up to 15 hours
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
up to 15 hours
Pharmacokinetic parameters of EACA in participants undergoing Posterior Spinal Fusion
up to 15 hours
Study Arms (2)
Idiopathic Scoliosis
Non-idiopathic Scoliosis
Eligibility Criteria
Children and Adolescents scheduled to have posterior spinal fusion surgery at The Children's Hospital of Philadelphia
You may qualify if:
- )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.
You may not qualify if:
- Wards of the State are not eligible
- Subjects with a history of abnormal renal function -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 25586726DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Stricker, MD
Children's Hospital of Philadelphia
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2011
First Posted
August 3, 2011
Study Start
July 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
August 9, 2013
Record last verified: 2013-08