Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

• Status: Suspended
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Tranexamic Acid

Criteria

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.