What is the safety and efficacy profile of Octaplasma® in children?
In the LAS 212 study,20 Octaplasma® was evaluated in 50 pediatric patients aged between 0 to 16 years in the perioperative setting. Investigators assessed overall safety in this study as ‘excellent’ for all 50 patients. No ADRs were reported including no hyper-fibrinolytic events or treatment-related thromboembolic events. Hemostatic parameters were within the expected ranges after using Octaplasma®.
In the LAS 213 study,21 the safety of Octaplasma® was evaluated in 41 patients requiring therapeutic plasma exchange (TPE) aged 2 to 20 years. No thrombotic or thromboembolic events or any other treatment-related serious adverse events were reported. Overall safety was assessed by investigators as excellent for >90% of patients 24 hours after each TPE throughout the study.
The studies support the use of Octaplasma® in managing perioperative or bleeding pediatric patients who require replacement therapy and for TPE in the plasma exchange.
