A Phase 3 interventional study of Tranexamic Acid and Tranexamic Acid in Craniosynostoses, sponsored by The Hospital for Sick Children. Suspended at 1 site in Canada. Open to participants aged 2 Months to 2 Years. Per ClinicalTrials.gov, last updated 2019-07-15.
Sponsored by The Hospital for Sick Children · Phase 3, Interventional, and Treatment
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's planned enrollment of 90 is above the median of 27 across 22 interventional studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure
Drug: Tranexamic Acid
TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure
Drug: Tranexamic Acid
Normal saline 10 ml before skin incision and infusion according to weight until skin closure
Drug: Saline Placebo
10 mg/kg bolus with a 5 mg/kg/h infusion
100 mg/kg bolus with a 10 mg/kg/h infusion
Blood Loss
Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.
Time frame: Prior and Post Surgery
Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples
PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery
Time frame: Sample will be drawn immediately after induction and prior to administration of study drug
Thromboelastography (TEG)Sample
TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis)
Time frame: Baseline, immediately after bolus dose of TXA is infused
This study is suspended, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
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