Amicar Pharmacokinetics of Children Having Craniofacial Surgery
| Status: | Archived |
|---|---|
| Conditions: | Other Indications, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2009 |
| End Date: | September 2011 |
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.
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 to accommodate the rapidly growing brain in infancy and early childhood.
Deformation of skull shape results as cranial vault expansion occurs in areas of the skull
that have not abnormally fused. Left uncorrected, craniosynostosis may adversely impact
neurologic and psychosocial development. In some cases, increased intracranial pressure may
also result.
Craniofacial (CF) reconstruction procedures to treat craniosynostosis are undertaken in
young children to improve appearance, prevent functional disturbances, and enhance
psychosocial development. Optimal surgical results are achieved when these procedures are
performed in infancy. These procedures are extensive, often requiring wide scalp
dissections and multiple osteotomies and have been associated with significant morbidity.
Reported complications include massive blood loss, intraoperative cardiac arrest,
transfusion reactions, venous air embolism, hypotension, coagulopathy, bradycardia,
postoperative seizures, surgical site infections, facial swelling, and unplanned
postoperative mechanical ventilation (7-13). Many of the most severe and commonly seen
problems are associated with the rate and extent of blood loss.
Intraoperatively, the presence of hyperfibrinolysis has been demonstrated in children
undergoing CF reconstruction procedures (8,14), although the extent of its contribution to
bleeding is unclear.
Epsilon-aminocaproic acid (EACA), another inhibitor of fibrinolysis, is an attractive
alternative. EACA is a synthetic lysine analog that blocks the lysine binding sites on
plasminogen, resulting in antifibrinolytic activity through inhibition of plasmin formation.
We have chosen to study EACA in this population.
We found this trial at
1
site
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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