Hetastarch increases the risk of bleeding complications in patients after off-pump coronary bypass surgery: a randomized clinical trial

Abstract

Objective: Hetastarch is an artificial colloid widely used intraoperatively in fluid-replacement regimens. Previous studies have found that the intraoperative administration of hetastarch may increase the risk of postoperative bleeding in patients who undergo coronary artery bypass graft surgery with cardiopulmonary bypass. Previous published reports have not examined this risk in patients who underwent coronary artery bypass grafting without cardiopulmonary bypass.

Methods: In a randomized clinical trial, 156 patients undergoing off-pump coronary artery bypass grafting were assigned to receive either 1 liter of hetastarch or 1 liter of albumin as part of intraoperative volume replacement. Sample recruitment was halted in a review per protocol by the study's Data Safety Monitoring Committee. We assessed the rate of postoperative bleeding by monitoring the number of units of blood products transfused in the first 24 postoperative hours in the intensive care unit and the hourly chest tube drainage in the first 12 postoperative hours.

Results: Intraoperative administration of 1 liter of hetastarch was associated with statistically significant increases in 3 measures: transfusion requirements on postoperative day 1 (red blood cells, 1.14 vs 0.40 units, P = .017; fresh-frozen plasma, 0.57 vs 0.15, P = .009; platelets, 0.35 vs 0.10, P = .013); the overall likelihood of receiving transfusion on postoperative day 1 (46.2% vs 25.6%, P = .012); and the volume of chest tube drainage in the first 12 hours postoperatively (732.0 vs 563.6 mL, P < .001).

Conclusion: In patients undergoing off-pump coronary artery bypass, the intraoperative administration of hetastarch increases the postoperative transfusion requirement and the volume of blood drained postoperatively.

Trial registration: ClinicalTrials.gov NCT00307138.