Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Blood Loss [ Time Frame: Prior and Post Surgery ] [ Designated as safety issue: No ]Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.
- Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples [ Time Frame: Sample will be drawn immediately after induction and prior to administration of study drug ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, immediately after bolus dose of TXA is infused ] [ Designated as safety issue: No ]TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis)
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Low Dose
TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure
Drug: Tranexamic Acid
10 mg/kg bolus with a 5 mg/kg/h infusion
Experimental: High Dose
TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure
Drug: Tranexamic Acid
100 mg/kg bolus with a 10 mg/kg/h infusion
Placebo Comparator: Placebo
Normal saline 10 ml before skin incision and infusion according to weight until skin closure
|Drug: Saline Placebo|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094977
|Contact: Tara Der, MD||416-813-7654 ext email@example.com|
|Contact: Carolyne Pehora, RN||416-813-7654 ext firstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada|
|Principal Investigator: Tara Der, MD|
|Sub-Investigator: Christian Zaarour, MD|
|Sub-Investigator: Mark Crawford, MD|
|Sub-Investigator: Guy Petroz, MD|
|Principal Investigator:||Tara Der, MD||The Hospital for Sick Children|