Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?
Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial and orthopedic surgery. In this prospective randomized double-blinded study, the investigators wish to evaluate the hypothesis that TXA is more effective than standard of care at decreasing blood loss and blood transfusion perioperatively in children and adolescents undergoing idiopathic scoliosis surgery.
Adolescent Idiopathic Scoliosis
Drug: Tranexamic Acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Efficacy of Intravenous Tranexamic Acid in Decreasing Blood Loss in Pediatric Idiopathic Scoliosis Surgery?|
- Perioperative blood loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]Perioperative blood loss ( i.e. intraoperative blood loss plus 24 hour postoperative blood loss) will be measured in mL/kg.
- Pharmacokinetic profile [ Time Frame: 2 years ] [ Designated as safety issue: No ]Population pharmocokinetic Nonlinear regression modeling of measured TXA concentrations will be conducted using NONMEM 7 software (ICON Development Solutions, Ellicott City, MD).
- DNA analysis of PAI-1 gene polymorphism [ Time Frame: 2 years ] [ Designated as safety issue: No ]DNA purification will be conducted using proteinase K, phenol-chloroform extraction, and ethanol precipitation. Analysis of PAI-1 gene polymorphism will be performed using primers and restriction endonuclease digestion.
- Plasma concentration of tranexamic acid [ Time Frame: 2 years ] [ Designated as safety issue: No ]Plasma tranexamic acid concentrations (ug/mL) will be measured by GC-MS.
- Perioperative transfusion of Packed red blood cells(PRBC) [ Time Frame: 2 years ] [ Designated as safety issue: No ]PRBC volume will be measured in mL/kg.
- Plasminogen activator inhibitor-1 (PAI-1) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Analysis of PAI-1 is done by ELISA, using the R&D Systems Quantikine kit (DSE100)
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery.
Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to:
Other Name: 0.9% Normal saline
Active Comparator: Tranexamic acid
Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.
Drug: Tranexamic Acid
Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:
Other Name: Cyklokapron, TXA, TA
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01813058
|Contact: Susan Goobie, MD, FRCPCfirstname.lastname@example.org|
|Contact: Timothy Hresko, MD||6173556000||Timothy.email@example.com|
|United States, Massachusetts|
|Boston Childrens Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Susan Goobie, Md, FRCPC|
|Sub-Investigator: Timothy Hresko, MD|
|Sub-Investigator: Navil Sethna, MD|
|Sub-Investigator: Mary Ellen McCann, MD|
|Sub-Investigator: Robert Brustowicz, MD|
|Sub-Investigator: Andres Navedo, MD|
|Sub-Investigator: Luis Pereira, PhD|
|Sub-Investigator: John Emans, MD|
|Sub-Investigator: Daniel Hedequest, MD|
|Sub-Investigator: Lawerence Karlin, MD|
|Sub-Investigator: David Zurakowski, PhD|
|Principal Investigator:||Susan Goobie, MD, FRCPC||Children's Hospital Boston|