Craniosynostoses Clinical Trial
Official title:
Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy
The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.
Blood loss during pediatric craniosynostosis surgery can be significant and this may be
exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit
allogeneic transfusions, although RCTs are few and limited. It is essential to investigate
these techniques to determine their potential to reduce allogeneic blood transfusions and
their associated cost and morbidity.
Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the
lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is
inhibition of fibrinolysis and clot degradation.
Recent studies in adults undergoing cardiac surgery demonstrated that people with different
genotypes for the plasminogen activator inhibitor-1 (PAI-1) gene may have varying degrees of
bleeding. PAI-1 inhibits the transformation of plasminogen to plasmin thereby decreasing
plasmin-induced fibrinolysis. Thus, PAI-1 promotes clot stability and the PAI-1 polymorphism
will affect the degree of bleeding and response to TXA during craniosynostosis surgery.
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