Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?
|ClinicalTrials.gov Identifier: NCT01813058|
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Drug: Tranexamic Acid Drug: Placebo||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Intravenous Tranexamic Acid in Decreasing Blood Loss in Pediatric Idiopathic Scoliosis Surgery?|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
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
- Perioperative blood loss [ Time Frame: 2 years ]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 ]Population pharmacokinetic 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 ]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 ]Plasma tranexamic acid concentrations (ug/mL) will be measured by GC-MS.
- Perioperative transfusion of Packed red blood cells(PRBC) [ Time Frame: 2 years ]PRBC volume will be measured in mL/kg.
- Plasminogen activator inhibitor-1 (PAI-1) [ Time Frame: 2 years ]Analysis of PAI-1 is done by ELISA, using the R&D Systems Quantikine kit (DSE100)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813058
|United States, Massachusetts|
|Boston Childrens Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Susan Goobie, MD, FRCPC||Boston Children’s Hospital|