Amicar Pharmacokinetics of Children Having Craniofacial Surgery
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 1
Details
Lead Sponsor:
Paul Stricker
Collaborators:
Children's Anesthesiology Associates, Ltd. Thomas B. and Jeannette E. Laws McCabe Fund Pilot Award