A randomised controlled trial of fibrinogen concentrate during scoliosis surgery

Area of Science:

• Orthopedic Surgery
• Hematology
• Pediatric Medicine

Background:

• Bleeding and the need for blood transfusions are frequent complications following scoliosis surgery.
• Fibrinogen plays a critical role in hemostasis and can be rapidly depleted during significant blood loss.

Purpose of the Study:

• To evaluate the efficacy of intra-operative fibrinogen concentrate in reducing peri-operative blood loss in pediatric patients undergoing idiopathic scoliosis surgery.
• To assess the impact of fibrinogen concentrate on the requirement for allogeneic red blood cell transfusions.

Main Methods:

• A randomized controlled trial involving 102 children aged 12-18 years undergoing idiopathic scoliosis surgery.
• Participants were allocated to receive either fibrinogen concentrate (30 mg.kg⁻¹, max 2 g) or a saline placebo during surgery.
• Peri-operative blood loss and the incidence of allogeneic red blood cell transfusion were primary outcome measures.

Main Results:

• Fibrinogen concentrate administration resulted in a statistically significant reduction in median peri-operative blood loss (155 ml, p=0.04).
• The median blood loss decreased from 1035 ml in the placebo group to 885 ml in the fibrinogen group.
• There was no significant difference in the rate of allogeneic red blood cell transfusion between the fibrinogen (7 children) and placebo (4 children) groups (p=0.34).

Conclusions:

• Intra-operative fibrinogen concentrate is effective in mitigating peri-operative blood loss during idiopathic scoliosis surgery in pediatric patients.
• The study found no adverse events associated with fibrinogen concentrate administration in this cohort.
• Fibrinogen concentrate represents a safe and potentially valuable adjunct for managing blood loss in pediatric scoliosis surgery.