A PROSPECTIVE STUDY TO DETERMINE PRACTICAL TRANEXAMIC ACID DOSING SCHEME BASED ON POPULATION PHARMACOKINETICS IN CHILDREN UNDERGOING CARDIAC SURGERY.
Background: Paediatric cardiac surgery patients are at high risk for bleeding and the antifibrinolytic drug tranexamic acid (TXA) is often used to reduce blood loss. However dosing schemes remain empirical as a consequence of the absence of pharmacokinetic study in this population. The authors’ objectives were thus to investigate the population pharmacokinetics of tranexamic acid (TXA) in paediatric cardiac surgery patients during cardiopulmonary bypass (CPB). Aims and objectives: To assist customize the TXA dosage; population pharmacokinetic modeling can be used to find differences in drug behaviour among various paediatric groups (e.g., based on age, weight, or other clinical parameters). To determine the difference between low dosage and high dosage tranexamic acid (TXA) in relation to activated clotting time (ACT). Materials and Methods: This is an prospective Randomized interventional comparative study in Department of Paediatric cardiac anesthesia and critical care,Shri Sathya sai sanjeevani Hospital Raipur and study duration was 1 year. The sample size of this study is 120. Result: In High dose TXA(100 mg/kg) with protamine, 5 (8.5%) patients had AP window with PMVSD, 5 (8.5%) patient had complete Atrio- ventricular canal defect, 1 (1.7%) patients had Doubly committed VSD, 2 (3.3%) patients had Inlet VSD, 2 (3.3%) patients had OS-ASD, 1 (1.7%) patient had Partial atrio ventricular canal defect, 18(30 %) patients had Perimembranous VSD, 11 (18.3%) patients had Tetralogy of fallot, 3 (5.1%) patients had TOF with Absent Pulmonary Valve, 12 (20.0%) patients had muscular VSD. In low dose TXA (30mg/kg) with protamine, 5 (8.3%) patients had OS- ASD, 45 (71.4%) patients had Perimembranous VSD, 8 (13.3%) patients had Tetralogy of fallot, 1 (1.7%) patient had muscular VSD,1 (1.7%) patient had VSD with DCRV. Conclusion: Based on population pharmacokinetics, this study offers a useful dosage schedule for tranexamic acid (TXA) in children having heart surgery. The pharmacokinetic diversity across various paediatric age groups and weight is properly taken into account in the established dosage regimen. It guarantees the best possible therapeutic doses while lowering the possibility of side effects from both under and overdose. With its ability to be tailored to clinical practise,the program gives medical professionals a dependable ,evidence based method of administering TXA to its high risk patient group.To improve the dosage plan and validate its clinical effectiveness and safety,more validation through clinical studies will be necessary.
To conclude high dose TXA is highly effective in indian paediatric cardiac surgery patients in comparison to low dose TXA without showing any adverse effects.To further confirm this more well designed and adequately powered randomised trials are needed.