Clinical trial NCT01094977: Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid
Official title: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Craniosynostoses
Keywords: Blood Loss and Transfusion
Craniosynostoses
Tranexamic Acid
Children
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Blood Loss
timeFrame: Prior and Post Surgery
Secondary outcomes:
measure: Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples
timeFrame: Sample will be drawn immediately after induction and prior to administration of study drug
measure: Thromboelastography (TEG)Sample
timeFrame: Baseline, immediately after bolus dose of TXA is infused
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Tara Der, MD
role: PRINCIPAL_INVESTIGATOR
References: