Research

Controlling Blood Loss During Surgery

Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery

Protocol Description

This study will investigate the potential benefit of using tranexamic acid, or cyklokapron, to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries. The correction of craniofacial deformities, particularly in small children and infants, results in unavoidable and significant blood loss. Intraoperative use of cyklokapron may reduce requirements for allogeneic transfusion requirements and the risks associated with blood transfusions.

Eligibility Criteria

Subject to certain exclusions, infants older than 6 months, who are scheduled for a primary or secondary repair of craniosynostosis, will be considered. While most participants will be between the ages of 6 months to 1 year, some individuals up to 18 years of age may be eligible to participate in this study.
Boys: Ages 6 months to 18 years
Girls: Ages 6 months to 18 years

Requirements
As this is a randomized trial, half the participants will be treated with cyklokapron and half will receive a placebo. During surgery cyklokapron or an equal amount of the placebo will be administered through an intravenous catheter over 15 minutes after the induction of anesthesia and before the skin incision. A maintenance infusion will follow and be continued until skin closures are completed. Blood work will be done during surgery to monitor effects of the study medicine on blood cells and blood clotting.
Visits: 1 Following surgery
Duration: Up to 3 days following surgery

Status: Open for Enrollment

Source of Support
University of Pittsburgh

Additional Resources
Study Description at National Institutes of Health