Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01094977|
Recruitment Status : Unknown
Verified August 2013 by Tara Der, The Hospital for Sick Children.
Recruitment status was: Recruiting
First Posted : March 29, 2010
Last Update Posted : August 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Craniosynostoses||Drug: Tranexamic Acid Drug: Saline Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
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 [ Time Frame: 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.
- Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples [ Time Frame: 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 [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094977
|Contact: Tara Der, MD||416-813-7654 ext firstname.lastname@example.org|
|Contact: Carolyne Pehora, RN||416-813-7654 ext email@example.com|
|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|