Craniosynostoses
Conditions
Keywords
Blood Loss and Transfusion, Craniosynostoses, Tranexamic Acid, Children
Brief 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.
Interventions
DRUGTranexamic Acid
10 mg/kg bolus with a 5 mg/kg/h infusion
DRUGSaline Placebo
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | Prior and Post Surgery | Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples | Sample will be drawn immediately after induction and prior to administration of study drug | PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery |
| Thromboelastography (TEG)Sample | Baseline, immediately after bolus dose of TXA is infused | TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis) |
Countries
Canada
Outcome results
None listed