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Prophylactic fibrinogen concentrate administration in surgical correction of paediatric craniosynostosis: A
Andreas Machotta1, Elise J Huisman, Inge M Appel
1From 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).
Insights
Prophylactic fibrinogen concentrate did not reduce blood loss or transfusions in pediatric craniosynostosis repair. This study found no significant differences in blood product transfusion or peri-operative blood loss.
Area of Science:
- Pediatric Surgery
- Anesthesiology
- Hematology
Background:
- Surgical craniosynostosis repair in children often involves substantial blood loss and transfusions.
- Fibrinogen concentrate is proposed to mitigate blood loss and transfusion needs.
Purpose of the Study:
- To evaluate the efficacy of prophylactic fibrinogen concentrate in reducing blood loss and transfusion requirements during pediatric craniofacial surgery.
Main Methods:
- A randomized, placebo-controlled, double-blind clinical trial was conducted.
- 114 infants and children undergoing craniosynostosis repair received either fibrinogen concentrate or a placebo.
- Outcomes included blood product volume, peri-operative blood loss, and other clinical parameters.
Main Results:
- No significant differences were observed in blood product volume transfused between the fibrinogen concentrate and placebo groups.
- Peri-operative blood loss (intra-operative, calculated, and postoperative) did not differ significantly between groups.
- Duration of surgery, ICU stay, hospital stay, and complication rates were also comparable.
Conclusions:
- Prophylactic high-dose fibrinogen concentrate administration does not effectively reduce blood product transfusions or peri-operative blood loss in pediatric craniosynostosis repair.
- The findings do not support the routine use of fibrinogen concentrate for this indication.
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 < 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.
Conclusion:
During 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 Registration:
National Trial Register (NTR2975) and EudraCT (2011-002287-24).
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