Study 1

Use of solvent/detergent-treated pooled plasma for therapeutic plasma exchange in children11

Objectives

Safety and tolerability of S/D plasma in the pediatric population.

Evaluation criteria

Adverse drug reactions, TEs, TEEs, safety laboratory parameters.

Results

Overall safety was assessed as excellent for >90% of patients 24 hours after each TPE. Most ADRs were mild in intensity and were resolved by end of study.

# of patients: 41

Study 2

Solvent/detergent-treated plasma in the management of pediatric patients who require replacement of multiple coagulation factors: an open-label, multicenter, post-marketing study12

Objectives

Collect real-world data on Octaplasma® treatment in paediatric patients with the primary focus being safety.

Evaluation criteria

Serious adverse events, adverse drug reactions, TEs, TEEs, HFEs.

Results

Overall safety ‘excellent’ for all patients. No AEs, no hyperfibrinolytic events and no TEEs related to Octaplasma®

# of patients: 50 (0–2 years, n=37; >2 years, n=13)

Cardiac surgery, n=40; LT and/or with LD; sepsis-related coagulopathy, n=4; hypoxic encephalopathy, n=1.

Adapted from Josephson et al and Spinella et al.