Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

The Hospital for Sick Children

Status and phase: Suspended; Phase 3

Conditions: Craniosynostoses

Treatments: Drug: Tranexamic Acid; Drug: Saline Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01094977

1000013836

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 2 months to 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Low Dose

Experimental group

Description:

TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure

Treatment:

Drug: Tranexamic Acid

Drug: Tranexamic Acid

High Dose

Experimental group

Description:

TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure

Treatment:

Drug: Tranexamic Acid

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

Normal saline 10 ml before skin incision and infusion according to weight until skin closure

Treatment:

Drug: Saline Placebo