Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Scoliosis

Keywords

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Pediatrics Scoliosis Pharmacokinetics Hemorrhage Orthopedic Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic Scoliosis

No interventions assigned to this group

Non-idiopathic Scoliosis

No interventions assigned to this group

Eligibility Criteria

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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 -

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Stricker, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 25586726 (View on PubMed)

Other Identifiers

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11-008205

Identifier Type: -

Identifier Source: org_study_id