Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

The Hospital for Sick Children90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Craniosynostoses

Interventions

Tranexamic AcidDRUG

10 mg/kg bolus with a 5 mg/kg/h infusion

Tranexamic AcidDRUG

100 mg/kg bolus with a 10 mg/kg/h infusion

Saline PlaceboDRUG

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction Exclusion Criteria: * Known bleeding disorder as this may increase the risk of bleeding * Current antifibrinolytic therapy as these patients may bleed less * Patient or family history of thromboembolic disease as there may be potential risk of thrombosis * Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding * Known allergy to TXA * History of renal insufficiency as TXA is renally excreted * Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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