Saturday, November 2, 2001 9:31–10:05 am Focused Review Concurrent: Deformity: 9:31 Use of Amicar versus Aprotinin during pediatric spinal deformity surgery

Abstract

Purpose of study: Our goal was to prospectively examine two groups of pediatric spinal deformity patients undergoing spinal fusion: “low-risk” and “high-risk” with respect to anticipated intraoperative blood loss, in order to determine the efficacy of randomly administered antifibrinolytics Amicar and Aprotinin in decreasing blood loss and transfusion requirements versus a placebo control.Methods used: Forty-seven patients in the “low-risk” group (eg, idiopathic patients undergoing single-stage ASF or PSF) were randomly assigned to receive Amicar (n = 27, bolus of 150 mg/kg before incision and 15 mg/kg infusion continuous to 4 hours after surgery) or placebo (n = 20). The mean age was 13 ± 9 years and mean weight was 52.4 kg. Forty-three patients in the “high-risk” group (eg, neuromuscular patients fused long to the pelvis) were randomized to receive Aprotinin (n = 20, 240 mg/m2 loading dose before incision and 56 mg/m2 infusion continuous to 4 hours after surgery) or placebo (n = 23). The mean age was 12 ± 8 years, and mean weight was 39.5 kg. Data assessed included estimated blood loss, transfusions from both cell-saver and units of blood both intraoperatively and perioperatively, and ending HCT. The entire operating room team (surgeons and anesthesiologists) were blinded to the drug groups provided.of findings: In the “low-risk” arm, there was no difference in Amicar versus placebo in calculated blood loss (891 cc vs. 874 cc, p > .05), number of PRBCs transfused (1.5 vs. 2.0, p > .05) and ending HCT (28.2% vs. 28.3%). In the “high-risk” arm, there were significant differences in the Aprotinin versus placebo group in calculated blood loss (1,190 cc vs. 2,158 cc, p < .05), number of PRBCs transfused (1.3 vs. 2.3, p < .05), amount of cell saver blood returned to the patient (81 cc vs. 293 cc, p < .05), whereas the ending HCT for both groups was the same (29.1% vs. 29.4%).Relationship between findings and existing knowledge: In “low-risk” pediatric patients having spinal deformity surgery, no difference in blood loss or transfusion requirements were observed when Amicar was administered versus placebo. However, in “high-risk” patients, Aprotinin significantly reduced blood loss and transfusion exposures during spinal deformity surgery versus placebo. This study was funded completely by the OREF.Overall significance of findings: The use of Aprotinin should be considered as a means of decreasing perioperative blood loss in those pediatric patients undergoing spinal deformity correction who are at high-risk for significant blood loss.Disclosures: Device or drug: Amicar and Aprotinin. Status: approved.Conflict of interest: No conflicts.