Effect of prophylactic fibrinogen concentrate in scoliosis surgery (EFISS): a randomised pilot trial

Abstract

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

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

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

Participants: 32 children undergoing scoliosis surgery entered and completed the study. The inclusion criteria were elective scoliosis surgery, age <18 years, provision of a signed informed consent form by both parents and consent to contraception use for the duration of this clinical trial among sexually active (≥15 years of age) participants. The exclusion criteria were diagnosed congenital or acquired coagulopathy, use of anticoagulants other than perioperative prophylactic administration of low molecular weight heparin to prevent venous thromboembolism, known hypersensitivity to the active substance or any excipients in the investigated medicinal product, history of deep vein thrombosis or pulmonary embolism, pregnancy and lactation.

Interventions: 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.

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

Results: 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.

Conclusions: 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.

Trial registration number: CliniacalTrials.gov NCT05391412.

Keywords: Blood bank & transfusion medicine; Paediatric anaesthesia; Scoliosis.

Figure 1. Flowchart diagram. ICF, Informed Consent Form.