The goal of this study is to assess the safety, feasibility and clinical outcomes of prophylactic fibrinogen administration in paediatric scoliosis surgery.

Prospective, two-arm, randomised, double-blind pilot trial.

Single-centre study conducted at a tertiary care hospital specialising in scoliosis surgery.

32 children undergoing scoliosis surgery entered and completed the study. The inclusion criteria were elective scoliosis surgery, age

Participants were randomised 1:1 to a standard group, receiving standard blood and coagulation management, or a fibrinogen group, receiving a single prophylactic dose of fibrinogen concentrate in addition to standard care.

Safety, the primary objective, was assessed according to adverse events, serious adverse events and other safety parameters. Secondary objectives included feasibility and clinical outcomes.

In the fibrinogen group, 101 adverse events across 19 types were observed, whereas in the standard group, 95 adverse events across 21 types (p>0.9999) and one serious adverse event were observed. No adverse events of special interest or deaths occurred in either group. Blood loss did not significantly differ between the fibrinogen (1021.88 mL (SD 473.63)) and standard (859.38 mL (SD 713.03)) groups (p=0.1677). The mean length of hospital stay was 8.88 (SD 0.81) days in the fibrinogen group and 9.25 (SD 1.88) days in the standard group (p=0.9210). No statistically significant differences in the use of blood transfusions, blood derivatives, crystalloids or colloids were observed between groups.

This study demonstrates that the prophylactic administration of fibrinogen during scoliosis surgery in children is feasible and appears to be safe. Due to the limited sample size, no conclusions can be drawn regarding the efficacy of pre-emptive fibrinogen administration on clinical outcomes. However, the results provide valuable data to inform sample size calculation for a future full-scale randomised controlled trial.

CliniacalTrials.gov NCT05391412.