Hextend (R), a physiologically balanced plasma expander for large volume use in major surgery: A randomized phase III clinical trial

Hestend((R)) (BioTime, Inc., Berkeley, CA) is a new plasma volume expander containing 6% hetastarch, balanced electrolytes, a lactate buffer, and phys iological levels of glucose. In preclinical studies, its use in shock model s was associated with an improvement in outcome compared with alternatives, such as albumin or 6% hetastarch in saline. In a prospective, randomized, two-center study (n = 120), we compared the efficacy and safety of Hextend( (R)) versus 6% hetastarch in saline (HES) for the treatment of hypovolemia during major surgery. Patients at one center had a blood sample drawn at th e beginning and the end of surgery for thromboelastographic (TEG) analysis. Hextend((R)) was as effective as HES for the treatment of hypovolemia. Pat ients received an average of 1596 mt of Hestend((R)): 42% received >20 mL/k g up to a total of 5000 mt. No patient received albumin. Hextend((R))-treat ed patients required less intraoperative calcium (4 vs 220 mg; P < 0.05). I n a subset analysis of patients receiving red blood cell transfusions (n = 56; 47%), Hextend((R))-treated patients had a lower mean estimated blood lo ss (956 mt less; P = 0.02) and were less likely to receive calcium suppleme ntation (P = 0.04). Patients receiving HES demonstrated significant prolong ation of time to onset of clot formation (based on TEG) not seen in the Hex tend((R)) patients (P < 0.05). No Hextend((R)) patient experienced a relate d serious adverse event, and there was no difference in the total number of adverse events between the two groups. The results of this study demonstra te that Hextend((R)), with its novel buffered, balanced electrolyte formula tion, is as effective as 6% hetastarch in saline for the treatment of hypov olemia and may be a safe alternative even when used in volumes up to 5 L. I mplications: Hextend((R)) (BioTime, Inc., Berkeley, CA) is a new plasma vol ume expander containing 6% hetastarch, balanced electrolytes, a lactate buf fer, and a physiological level of glucose. It is as effective as 6% hetasta rch in saline for the treatment of hypovolemia but has a more favorable sid e effects profile in volumes of up to 5 L compared with 6% hetastarch in sa line.