Bleeding Clinical Trial
Official title:
Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.
Surgical procedures for the correction of craniofacial deformities result in unavoidable and
significant blood loss in small children and infants. Patients may experience blood losses
that exceed one to two blood volumes. In an effort to reduce our transfusion requirements,
we have introduced tranexamic acid into our practice. However, the benefit of tranexamic
acid in pediatric craniofacial surgery has not yet been reported. We hypothesize that the
intraoperative use of tranexamic acid in pediatric patients presenting for craniofacial
reconstructions will reduce blood loss and allogeneic transfusion requirements.
This is a randomized, blinded, prospective study that will investigate the potential benefit
of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric
patients undergoing craniofacial surgeries. An initial dose of 100 mg/kg tranexamic acid
(Cyclokapron 100mg/ml) or an equal volume of a placebo will be administered over 15 minutes
after the induction of anesthesia and before the skin incision. A maintenance infusion of 10
mg/kg/hr of tranexamic acid or equal volume of a placebo will be started upon completion of
the initial dose and will be continued until skin closure. The primary outcome will include
the reduction in the total volume of allogeneic erythrocytes.
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