Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery

Abstract

Study design: : Randomized, placebo-controlled trial.

Objective: : To evaluate the efficacy of epsilon aminocaproic acid (EACA) to reduce the number of red-cell (RBC) transfusions in adult patients undergoing major spinal surgery.

Summary of background data: : Reconstructive spinal surgery is associated with significant blood loss. The number of studies evaluating the efficacy of EACA in adult patients undergoing spinal surgery remains scarce and limited.

Methods: : EACA (100 mg/kg) or placebo was administered to 182 adult patients after the induction of anesthesia followed by an infusion that was continued for 8 hours after surgery. Primary end points included total allogeneic RBC transfusions through postoperative day 8 and postoperative allogeneic plus autologus RBC transfusions through postoperative day 8.

Results: : Mean total allogeneic RBC transfusions were not statistically different between the groups (5.9 units EACA vs. 6.9 units placebo; P = 0.17). Mean postoperative RBC transfusions in the EACA group was less (2.0 units vs. 2.8 units placebo; P = 0.03). There was no significantdifference in mean estimated intraoperative estimated-blood loss (2938 cc EACA vs. 3273 cc placebo; P = 0.32). Mean intensive care unit length of stay was decreased (EACA: 1.8 days vs. 2.8 days placebo; P = 0.04). The incidence of thromboembolic complications was similar (2.2% EACA vs. 6.6% placebo; P = 0.15).

Conclusion: : The difference in total allogeneic RBC transfusions between the groups was not statistically significant. EACA was associated with a 30% (0.8 units) reduction in postoperative RBC transfusions and a 1-day reduction in ICU LOS, without an increased incidence of thromboembolic events. EACA may be considered for patients undergoing major spinal surgery. Larger studies are needed to evaluate the relationship between EACA and total RBC requirements.

Trial registration: ClinicalTrials.gov NCT00320619.

Figures

Figure 1

Screening and Enrollment of Study Patients.

Figure 2. Total allogeneic RBC transfusions

The box-plot represents the distribution of allogeneic RBC units transfused per patient during intraoperative period through postoperative day 8. The box represents the 25th to 75th percentile and the center line in the box represents the 50th percentile of units transfused. The bars above and below the box represent the range of units transfused. Mean and median total allogeneic RBC transfusions was only slightly decreased in the EACA group compared to the placebo group relative to the decrease in the upper range of the number of units transfused

Figure 3. Postoperative RBC transfusions

The box-plot represents the distribution of allogeneic and autologous RBC units transfused per patient during the postoperative period (post-surgery through postoperative day 8). The box represents the 25th to 75th percentile and the center line in the box represents the 50th percentile of units transfused. The bars above and below the box represent the range of units transfused. Mean and median postoperative RBC transfusions was only slightly decreased in the EACA group compared to the placebo group relative to the decrease in the upper range of the number of units transfused.