None listed
Conditions
Brief summary
Scoliosis surgery is often associated with substantial blood loss due to the extensive exposure and instrumentation.Despite common blood conservation strategies and improved surgical techniques used, more than half of patients underwent this procedure received blood transfusion. Concerns of transfusion related complications have revived interest in hemostatic pharmaceuticals, Tranexamic acid (TA) is a lysine analogue anti-fibrinolytic drug that inhibits degradation of fibrin. Recent meta-analysis has shown that TA is effective in reducing amount of blood loss and the volume of blood transfusion, The efficacy of TA has been postulated to be dose-dependent, but there is no standard guidelines and adequate pharmacokinetic modelling study on the most appropriate dosing regimen and administration, as well as prevention of adverse events such as thromboembolism and seizure risk. We aims to conduct this randomized study to determine the efficacy of high dose versus low dose Tranexamic Acid in surgery for adolescent idiopathic scoliosis. Primary outcome for this study is to determine the mean total blood loss and also transfusion requirement. Secondary outcome is to assess the perioperative trend of Hematological parameters and also to look at the 6-hours plasma level of Tranexamic acid post-operatively. A total of 160 patients (80 per group) who will be undergo elective single-staged idiopathic scoliosis surgery (posterior repair only)in University Malaya Medical Centre, Federal Territory, Malaysia between March 2017 and March 2018 will be recruited in this study.
Interventions
This study aims at determine the efficacy of Tranexamic Acid in adolescent idiopathic scoliosis surgery. A total of 160 patients are assigned into 2 groups (80 patients each)- high dose (30mg/kg loading dose over 15 minutes 30 to 60 minutes prior to surgical incision, follow by 10mg/kg/hour ) or low dose (10mg/kg loading dose over 15 minutes at 30-60minutes prior to surgical incision; follow by 1mg/kg/hour) Tranexamic Acid Regime.
Tranexamic Acid 500mg/5ml injection Bioindustria laboratorio Ita
This study aims at determine the efficacy of Tranexamic Acid in adolescent idiopathic scoliosis surgery. A total of 160 patients are assigned into 2 groups (80 patients each)- high dose (30mg/kg loading dose over 15 minutes 30 to 60 minutes prior to surgical incision, follow by 10mg/kg/hour ) or low dose (10mg/kg loading dose over 15 minutes at 30-60minutes prior to surgical incision; follow by 1mg/kg/hour) Tranexamic Acid Regime. Tranexamic Acid 500mg/5ml injection Bioindustria laboratorio Italiano Medinali (L.I.M) will be adminstered to the patients. Total intraoperative Blood loss will be calculated from the cell salvage system as well as weighing the soaked sponges. This collected cell salvage blood will be re-infused to patient at the completion of surgery. For all groups,Ringer’s lactate solution will be used throughout the operation as maintenance fluid therapy and as replacement for insensible fluid loss in accordance with Holliday-Segar formula. Should the patient developed hypotension with MAP < 60mmHg or tachycardia >20% from baseline intraoperatively, additional 5mls/kg bolus of Ringer’s lactate solution will be given to patient and can be repeated up to 4 times if necessary. However, if persistent hemodynamic instability and there is more than 20% loss of blood volume, collected cell salvage blood will be transfused back to patient immediately. Allogenic blood would be administered when the intraoperative Hemoglobin concentration fell below 8gdl-1 despite completion of autologous blood and adequate fluid resuscitation with persistent hemodynamic instability i.e. persistent hypotension or tachycardia >20% from baseline. Patients with postoperative Hemoglobin value of less than 8gdl-1 will also receive one unit of allogenic packed red cell transfusion. All patients will be followed up until hospital discharge and within 30 days post-operation period.
Sponsors
Associate Professor Dr. Mohd Shahnaz Hasan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
10 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
Patients who will be undergo elective single-staged idiopathic scoliosis surgery (posterior repair only)in University Malaya Medical Centre, Federal Territory, Malaysia between March 2017 and March 2018 American Society of Anesthesiologists (ASA) physical status I and II preoperative hemoglobin level > 10 g/dL preoperative platelet level > 150,000/L written informed consent
Exclusion criteria
Severe Hematological disorder Patients who receive anticoagulants and antiplateletswithin 14 days prior to operation Severe cardiac disease (Aortic stenosis or cardiac ejection fraction <40%; Myocardial infarction in the previous 6 months; myocardial ischemia on resting Electrocardiogram) Severe pulmonary disease (FEV1 < 50% predicted, PaO2 < 9 kPa on air) Preoperative creatinine >200 mmol/L Serum Aspartate aminotransferase (AST)>100 IU/L
Outcome results
None listed