Status:
COMPLETED
Amicar Pharmacokinetics of Children Having Craniofacial Surgery
Lead Sponsor:
Paul Stricker
Collaborating Sponsors:
Children's Anesthesiology Associates, Ltd.
Thomas B. and Jeannette E. Laws McCabe Fund Pilot Award
Conditions:
Craniosynostosis
Eligibility:
All Genders
2-24 years
Phase:
PHASE1
Brief Summary
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 dissect...
Detailed Description
Craniosynostosis is the condition in which there is premature fusion of one or more of these sutures between the bones of the skull. Craniosynostosis limits the ability of the cranial vault to expand ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00912119
Start Date
May 1 2009
End Date
October 1 2011
Last Update
November 1 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104