Prophylactic fibrinogen concentrate administration in surgical correction of paediatric craniosynostosis: A double-blind placebo-controlled trial

BACKGROUND Surgical craniosynostosis repair in children is associated with massive blood loss and significant transfusion of blood products. Fibrinogen concentrate is claimed to be useful in reducing blood loss and transfusion requirements. OBJECTIVE We investigated whether prophylactic administration of fibrinogen concentrate will reduce blood loss and transfusion requirements during paediatric craniofacial surgery. DESIGN Randomised, placebo-controlled, double-blind clinical trial. SETTING University medical centre. PATIENTS A total of 114 infants and children up to 25 months of age (median age 10 months). INTERVENTION Surgical craniosynostosis repair by calvarial remodelling was performed in each patient. Patients were randomised to receive prophylactic fibrinogen concentrate (Haemocomplettan P) at a mean dose of 79 mg kg−1 body weight or placebo. MAIN OUTCOME MEASURES Primary outcome was the volume of transfused blood products. Secondary outcomes were peri-operative blood loss, duration of surgery, length of stay in the paediatric ICU, length of hospital stay, postoperative complications and adverse effects of fibrinogen concentrate infusion. RESULTS No significant differences (P 
Source: European Journal of Anaesthesiology - Category: Anesthesiology Tags: Haemostasis-transfusion Source Type: research