Does Tranexamic Acid Decrease Blood Loss in Pediatric 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
Show Detailed Description
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|