Amicar Pharmacokinetics of Children Having Craniofacial Surgery

Completed · Phase 1

Conditions studied: Craniosynostosis

In brief

Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. The surgery is extensive, often requiring wide scalp dissections and multiple osteotomies and has been associated with significant morbidity. Some of the most severe and commonly seen problems are associated with the rate and extent of blood loss. Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and a lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of fibrinolysis, reduces transfusion requirements in children undergoing procedures on cardiopulmonary bypass (CPB), as well as in older children undergoing spinal surgery for scoliosis (1-6). Before controlled studies to assess efficacy of EACA in a craniofacial surgical population can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal dosing strategy. PK data exist for EACA in children undergoing operations on CPB and hypothermia. The aim of this study is to determine the pharmacokinetics of EACA in infants and children undergoing craniofacial reconstruction procedures.

Key facts

Study ID

NCT00912119

Run by

Paul Stricker

People needed

18

Starts

2009-05-01

Expected to finish

2011-10-01

Last updated by the study team

2012-11-01

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females of every race and ethnicity ages 2 months- 24 months
• Diagnosis - Craniosynostosis (including syndromic craniosynostosis)
• Surgical procedure - Pediatric patients undergoing craniofacial reconstruction procedures involving a craniotomy
• Written informed parent/guardian consent

You may not qualify if…

• Children with known or suspected hypersensitivity reaction to epsilon-aminocaproic acid
• Subjects who do not have a parent or legal guardian who speaks English
• Presence of a known coagulation abnormality
• Presence of hematuria
• Presence of a preoperative coagulation test abnormality (PT or PTT outside of normal range)
• Known history of a coagulation disorder in either parent. Children in whom this history is not available (e.g., adopted children) will be eligible for study inclusion.
• History of abnormal renal function
• Serum creatinine or blood urea nitrogen (BUN) value outside of normal range (collected within 30 days of proposed EACA administration)
• Initial intra-operative serum creatinine or BUN value outside of normal range
• Children undergoing strip craniectomy for sagittal craniosynostosis
• Presence of a preexisting neurologic deficit, seizure disorder, or other neurologic disorder
• History of congenital cardiac disease (does not include patent ductus arteriosis, patent foramen ovale, or spontaneously closed muscular ventricular septal defect)
• Children having other surgical procedures performed in addition to craniofacial reconstruction surgery
• Preoperative laboratory abnormalities that indicate clinically significant hematologic disease (collected within 30 days of proposed EACA administration):
• Hemoglobin < 9 gm/dL Platelet count < 100,000/mm3
• Any investigational drug use within 30 days prior to proposed EACA administration.
• Wards are not eligible for study
• Children who have been previously enrolled in this study may not be enrolled again.

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.