• Andreas Machotta, Elise J Huisman, Inge M Appel, Saskia E Luijnenburg, Marta Lopez-Yurda, Marjon H Cnossen, and Cornelia H van Ommen.
• From the Department of Paediatric Anaesthesiology (AM), Department of Paediatric Haematology, Erasmus University Medical Centre - Sophia Children's Hospital, Rotterdam (EJH, IMA, SEL, MHC, CHvO) and Department of Biometrics, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands (ML-Y).
• Eur J Anaesthesiol. 2021 Sep 1; 38 (9): 908-915.

BackgroundSurgical 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.ObjectiveWe investigated whether prophylactic administration of fibrinogen concentrate will reduce blood loss and transfusion requirements during paediatric craniofacial surgery.DesignRandomised, placebo-controlled, double-blind clinical trial.SettingUniversity medical centre.PatientsA total of 114 infants and children up to 25 months of age (median age 10 months).InterventionSurgical 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 MeasuresPrimary 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.ResultsNo significant differences (P < 0.05) were found in the volume of transfused blood products (median 29 ml kg-1 body weight vs. 29 ml kg-1 body weight), intra-operative estimated blood loss (45 vs. 46 ml kg-1), calculated blood loss (57 vs. 53 ml kg-1), or postoperative blood loss (24 vs. 24 ml kg-1) between the intervention and placebo groups. In addition, duration of surgery, length of stay in the paediatric ICU, hospital stay and complications were not significantly different between the two groups.ConclusionDuring surgical craniosynostosis repair in young children, prophylactic administration of high-dose fibrinogen concentrate did not reduce the amount of transfused blood products or decrease peri-operative blood loss.Trial RegistrationNational Trial Register (NTR2975) and EudraCT (2011-002287-24).Copyright © 2020 European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.

12 keywords...

hide…