Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Scoliosis

Study type: Observational

Funder types: Other

Identifiers

NCT01408823

11-008205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

20 participants in 2 patient groups

Idiopathic Scoliosis

Non-idiopathic Scoliosis