Use of Amicar vs. Aprotinin During Pediatric Spinal Deformity Surgery: Can they Help Decrease Blood Loss?
Abstract from the SRS 2002 Annual Meeting
Purpose: 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 intraop blood loss, in order to determine the efficacy
of randomly administered antifibrinolytics Amicar and Aprotinin in decreasing
blood loss and transfusion requirements vs. a placebo control.
Methods: 47 pts in the low-risk group (e.g. idiopathic patients undergoing single stage ASF or PSF) were randomly assigned to receive Amicar (n=27, bolus of 150mg/kg pre-incision and 15mg/kg infusion cont. to 4 hrs. postop) or placebo (n=20). The mean age was 13+9 years and mean weight was 52.4 kg. 43 pts in the high-risk group (e.g. neuromuscular pts fused long to the pelvis) were randomized to receive Aprotinin (n=20, 240mg/m2 loading dose pre-incision and 56mg/m2 infusion cont. to 4 hrs. postop) or placebo (n=23). The mean age was 12+8 years and mean weight was 39.5 kg. Data assessed included estimated blood loss (EBL), transfusions from both cell-saver and units of blood both intraop and periop, and ending HCT. The entire operating room team (surgeons and anesthesiologists) were blinded to the drug groups provided.
Results: In the low-risk arm, there was no difference in Amicar vs. placebo in calculated blood loss (891cc vs. 874cc, p>.05); #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 vs. placebo group in calculated blood loss (1190cc vs. 2158cc, p<.05); #PRBCs transfused (1.3 vs. 2.3, p<.05); amount of cell saver blood returned to the patient (81cc vs. 293cc, p<.05); while the ending HCT for both groups was the same (29.1% vs. 29.4%).
Conclusions: In low-risk pediatric patients having spinal deformity surgery, no difference in blood loss or transfusion requirements were observed when Amicar was administered vs. placebo. However, in high-risk patients, Aprotinin significantly reduced blood loss and transfusion exposures during spinal deformity surgery vs. placebo.
This study was funded completely by the OREF.
Methods: 47 pts in the low-risk group (e.g. idiopathic patients undergoing single stage ASF or PSF) were randomly assigned to receive Amicar (n=27, bolus of 150mg/kg pre-incision and 15mg/kg infusion cont. to 4 hrs. postop) or placebo (n=20). The mean age was 13+9 years and mean weight was 52.4 kg. 43 pts in the high-risk group (e.g. neuromuscular pts fused long to the pelvis) were randomized to receive Aprotinin (n=20, 240mg/m2 loading dose pre-incision and 56mg/m2 infusion cont. to 4 hrs. postop) or placebo (n=23). The mean age was 12+8 years and mean weight was 39.5 kg. Data assessed included estimated blood loss (EBL), transfusions from both cell-saver and units of blood both intraop and periop, and ending HCT. The entire operating room team (surgeons and anesthesiologists) were blinded to the drug groups provided.
Results: In the low-risk arm, there was no difference in Amicar vs. placebo in calculated blood loss (891cc vs. 874cc, p>.05); #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 vs. placebo group in calculated blood loss (1190cc vs. 2158cc, p<.05); #PRBCs transfused (1.3 vs. 2.3, p<.05); amount of cell saver blood returned to the patient (81cc vs. 293cc, p<.05); while the ending HCT for both groups was the same (29.1% vs. 29.4%).
Conclusions: In low-risk pediatric patients having spinal deformity surgery, no difference in blood loss or transfusion requirements were observed when Amicar was administered vs. placebo. However, in high-risk patients, Aprotinin significantly reduced blood loss and transfusion exposures during spinal deformity surgery vs. placebo.
This study was funded completely by the OREF.
Last Updated: 04/26/2005
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