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Effect of prophylactic fibrinogen concentrate in scoliosis surgery (EFISS): a randomised pilot trial
Jan Hudec1,2, Kamil Vrbica1,2, Ondrej Hrdy3,2
1Department of Anaesthesiology and Intensive Care Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Insights
Prophylactic fibrinogen concentrate administration in paediatric scoliosis surgery appears safe and feasible. Further research is needed to determine its efficacy on clinical outcomes in children undergoing spinal fusion.
Area of Science:
- Paediatric Orthopaedic Surgery
- Haemostasis and Thrombosis
- Clinical Trial Design
Background:
- Scoliosis surgery in children can involve significant blood loss.
- Fibrinogen concentrate is a blood product used to manage bleeding.
- The safety and efficacy of prophylactic fibrinogen in paediatric scoliosis surgery require investigation.
Purpose of the Study:
- To assess the safety and feasibility of prophylactic fibrinogen administration in paediatric scoliosis surgery.
- To evaluate the clinical outcomes associated with this intervention.
- To gather data for future large-scale randomized controlled trials.
Main Methods:
- A prospective, randomized, double-blind, pilot trial involving 32 children undergoing scoliosis surgery.
- Participants were randomized to receive either standard care or standard care plus a single prophylactic dose of fibrinogen concentrate.
- Safety was assessed via adverse events, while feasibility and clinical outcomes were secondary objectives.
Main Results:
- No significant differences in adverse events or serious adverse events were observed between the fibrinogen and standard care groups.
- Blood loss, hospital stay, and use of blood products did not significantly differ between the groups.
- The study demonstrated the feasibility and apparent safety of prophylactic fibrinogen administration.
Conclusions:
- Prophylactic fibrinogen administration in paediatric scoliosis surgery is feasible and appears safe.
- The pilot study's limited sample size precludes definitive conclusions on efficacy for clinical outcomes.
- Results provide essential data for designing future, larger randomized controlled trials.
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.
