Background: The synthetic colloid hydroxyethyl starch (HES) received a black box warning, issued by the US Food and Drug Administration (FDA) in June 2013, in patients with sepsis, due to increased risk of bleeding, renal injury, and death. Risks of HES in populations undergoing noncardiac surgery are unclear. Here, we examine the association of colloid choice - human-derived albumin versus HES - with bleeding in musculoskeletal surgery.
Methods: Inpatient musculoskeletal surgical patients who received colloids on the day of surgery were included during a time period before the FDA warning on HES using the Premier Healthcare database. The exposure was type of colloids administered on the day of surgery: HES versus albumin. The primary outcome was major perioperative bleeding, measured on the 1st postoperative day through hospital discharge. The secondary outcomes included acute renal failure and postoperative length of stay >75th percentile.
Results: We identified 41,211 patients who received albumin (n = 12,803) and HES (n = 28,408) on the day of surgery. The propensity-weighted multivariable analysis demonstrated a reduced risk of major perioperative bleeding on the day after surgery following treatment with albumin versus HES (relative risk: 0.89 [95% confidence interval, 0.84-0.93]). No significant differences were observed in the secondary outcomes.
Conclusion: When compared with albumin, treatment with HES on the day of musculoskeletal surgery was associated with an increased risk of major perioperative bleeding on subsequent days. Given that HES continues to be used as a colloid in multiple patient populations worldwide, further studies examining the safety of HES versus albumin solutions are needed.
Keywords: Hemorrhage; hydroxyethyl starch derivatives; orthopedic procedures; surgical blood loss.
Copyright: © 2021 International Journal of Critical Illness and Injury Science.