HextendT, a Physiologically Balanced Plasma Expander for Large Volume Use in Major Surgery: A Randomized Phase III Clinical Trial

Hextendt (BioTime, Inc., Berkeley, CA) is a new plasma volume expander containing 6% hetastarch, balanced electrolytes, a lactate buffer, and physiological levels of glucose. In preclinical studies, its use in shock models was associated with an improvement in outcome compared with alternatives, such as albumin or 6% hetastarch in saline. In a prospective, randomized, twocenter study (n 5 120), we compared the efficacy and safety of Hextendt versus 6% hetastarch in saline (HES) for the treatment of hypovolemia during major surgery. Patients at one center had a blood sample drawn at the beginning and the end of surgery for thromboelastographic (TEG) analysis. Hextendt was as effective as HES for the treatment of hypovolemia. Patients received an average of 1596 mL of Hextendt: 42% received .20 mL/kg up to a total of 5000 mL. No patient received albumin. Hextendt-treated patients required less intraoperative calcium (4 vs 220 mg; P , 0.05). In a subset analysis of patients receiving red blood cell transfusions (n 5 56; 47%), Hextendt-treated patients had a lower mean estimated blood loss (956 mL less; P 5 0.02) and were less likely to receive calcium supplementation (P 5 0.04). Patients receiving HES demonstrated significant prolongation of time to onset of clot formation (based on TEG) not seen in the Hextendt patients (P , 0.05). No Hextendt patient experienced a related serious adverse event, and there was no difference in the total number of adverse events between the two groups. The results of this study demonstrate that Hextendt, with its novel buffered, balanced electrolyte formulation, is as effective as 6% hetastarch in saline for the treatment of hypovolemia and may be a safe alternative even when used in volumes up to 5 L. Implications: Hextendt (BioTime, Inc., Berkeley, CA) is a new plasma volume expander containing 6% hetastarch, balanced electrolytes, a lactate buffer, and a physiological level of glucose. It is as effective as 6% hetastarch in saline for the treatment of hypovolemia but has a more favorable side effects profile in volumes of up to 5 L compared with 6% hetastarch in saline.