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Surgery for craniosynostosis is often undertaken in the first year of life and involves complete remodeling of surrounding bone in order to obtain the best aesthetic and functional result.
Reported averages of EBL during surgery are 80-150% of EBV. The majority of blood is replaced within 4 hours in the operating room, usually with plasma-poor PRBCs. This leads to a dilutional coagulopathy, adversely impacting blood loss requiring more PRBCs thus establishing a negative feedback cycle. Based on retrospective trials, some centers currently use 1:1 plasma: blood for craniosynostosis surgeries. To further verify this practice, we have undertaken a prospective, randomized controlled trial to test the hypothesis that early and consistent administration of FFP in the OR improves hemostasis in children undergoing correction of craniosynostosis and thereby decreases blood loss and transfusion needs.
In this approved IRB study, 73 patients have undergone frontal orbital advancement and/or total calvarial reshaping and expansion. Exclusion criteria included age over two years at time of surgery , a history of CHD, coagulopathy, liver or kidney disease. Patients were randomized to one of two groups, with the intervention group receiving PRBC and FFP in equal volumes (10 ml/kg) while the control group receiving only PRBC (10 ml/kg).
Goal Hct for the end of the surgery was 28%. A CBC and coagulation panel (Protime, activated partial thromboplastin time, and Fibrinogen) were obtained at Blood loss was calculated as previously described formula:
ERCVlost = ERCVpreop + ERCVtransfused - ERCVpostop
Power analysis was undertaken with the assumption that a 20% reduction in transfusion would be clinically significant. Two-sided α was assigned at 0.05.
Although more albumin and less FFP was administered in the control group the two groups were not significantly different for total colloid (FFP plus albumin). Coagulation values were significantly improved with the use of prophylactic FFP as reflected by improved PT, aPTT, and fibrinogen values in the treatment group. The need for FFP or cryoprecipitate postoperatively was less in the treatment group (17% vs. 0%; P < 0.05). Donor exposures in the OR and postoperatively were comparable.
The use of prophylactic FFP in patients undergoing primary repair of craniosynostosis is associated with improvement in intra and postoperative coagulation values and a significant reduction in the need for postoperative FFP or cryoprecipitate.