NCT01094977

Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

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

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 2 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Craniosynostoses

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	10 mg/kg bolus with a 5 mg/kg/h infusion
DRUG	Tranexamic Acid	100 mg/kg bolus with a 10 mg/kg/h infusion
DRUG	Saline Placebo

Timeline

• Start date: 2010-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2010-03-29
• Last updated: 2019-07-15

Locations

1 site across 1 country: Canada