Last reviewed · How we verify
Pharmacokinetics of Epsilon-Aminocaproic Acid in Children Undergoing Craniofacial Reconstruction Surgery
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.
Details
| Lead sponsor | Paul Stricker |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2009-05 |
| Completion | 2011-10 |
Conditions
- Craniosynostosis
Interventions
- Epsilon-Aminocaproic Acid
- Epsilon-Aminocaproic Acid
- Epsilon-Aminocaproic Acid
- Epsilon-Aminocaproic Acid
Primary outcomes
- pharmacokinetic parameters of EACA including clearance, AUC0-∞, half-life, and volume of distribution — 80 hours
Countries
United States