Objective: The current non-inferiority, prospective, randomized study compared the efficacy and safety of the third generation, starch-based volume expander tetraspan (TS) to human albumin solution (ALB). Following the FDA`s declaration doubting the safety of starch solutions use as volume expanders in critically ill patients (2013), we discontinued recruiting patients and performed a data analysis. Postoperative bleeding during the first 48 hours was defined as the primary outcome measure.
Methods: Patients admitted for open-heart surgery were prospectively randomized to perioperative volume replacement therapy with TS or ALB. Preoperative variables were demographics, aspirin and plavix use, baseline creatinine, and procedure type. Pre- and postoperative variables were coagulation profiles, thromboelastography (TEG) and creatinine. Intraoperatively, bypass time and minimal temperature were monitored. Intra- and postoperative volumes of used TS and ALB were recorded. Postoperative bleeding, RBC and blood products use during ICU stay, acute kidney injury, hospitalization length and 30-day in-hospital mortality were assessed.
Results: Thirty patients fulfilled the study protocol (TS group: n=18; ALB group: n=12). Perioperative TS and ALB volumes were comparable (5095±288cc vs. 5174±332cc, respectively; P=0.923). The TS group demonstrated excess postoperative bleeding compared to the ALB group (median [25th-75th percentiles]: 965 [560-1312.5] vs. 610 [488.7-937] cc, respectively; P=0.038). Both groups were comparable in terms of all other variables (Ps>0.1). No renal replacement therapy or mortality cases were recorded.
Conclusion Increased bleeding was detected in patients treated with TS as compared to ALB after open heart surgery, although used volumes were comparable. This justifies vigilance before resumption of starch-based solutions ALB volume expanders in patients undergoing open-heart surgery.
