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PURPOSE:
Surgery for craniosynostosis is often associated with extensive blood loss in the operating room with reported averages of 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, which presumably adversely impacts blood loss requiring more PRBCs thus establishing a negative feedback cycle. Based on retrospective trials, some centers currently use 1:1 plasma: blood in an attempt to reduce blood loss. To verify this practice, we undertook a prospective, randomized controlled trial to test the hypothesis that early and consistent administration of Fresh Frozen Plasma (FFP) in the OR improves hemostasis in children undergoing correction of craniosynostosis and thereby decreases blood loss and transfusion needs.
METHODS:
In this approved IRB study, written informed consents were obtained from the families of 73 patients scheduled to undergo FOA and/or TCVE. 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).
Volume resuscitation intra-operatively was accomplished with either PRBC or 5 % albumin according to protocol. 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 four times for each patient: approximately two weeks prior to surgery (T1), intra-operatively after all skull bone removal (T2), immediately postoperatively (T3), and six hours postoperatively (T4). In the OR and PACU hemostatic parameters were treated according to protocol.
Blood loss was calculated according to the formula:
ERCV_lost = ERCVpreop + ERCV_transfused - ERCV_postopPower analysis was undertaken with the assumption that a 20% reduction in transfusion would be clinically significant.
RESULTS:
At this time a total of 73 patients have been enrolled and 71 analyzed due to exclusion because of extreme hemodynamic instability intra-operatively (one in each group).
Groups were similar with respect to demographic and intra-operative fluid requirements. 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). Time points T1-T4 showed similar Hct values between groups, indicating compliance with a strict transfusion protocol. There was no difference in PRBC requirements either intra or postoperatively. Coagulation values were significantly improved with the use of prophylactic FFP as reflected by improved PT, aPTT, and fibrinogen values in the treatment group at T2-T4. 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.
CONCLUSION:
The use of prophylactic FFP in patients undergoing primary repair of craniosynostosis did not change the PRBC transfusion requirement. However, it was associated with improvement in intra and postoperative coagulation values and a significant reduction in the need for postoperative FFP or cryoprecipitate.