Hextend[registered sign], a Physiologically Balanced Plasma Expander for Large Volume Use in Major Surgery: A Randomized Phase III Clinical Trial

• Published in: Anesthesia and analgesia Vol. 88; no. 5; pp. 992 - 998
• Main Authors: Gan, T. J, Bennett-Guerrero, E, Phillips-Bute, B, Wakeling, H, Moskowitz, D. M, Olufolabi, Y, Konstadt, S. N, Bradford, C, Glass, P. S. A, Machin, S. J, Mythen, M. G
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD International Anesthesia Research Society 01.05.1999; Lippincott
• Subjects: Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis; Medical sciences; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Human; Hypovolemia; Toxicity; Treatment efficiency; Intraoperative; Colloid; Plasma substitute; Treatment; Surgery; Dosage form; Complication; Hemodynamics; Starch(hydroxyethyl)
• ISSN: 0003-2999; 1526-7598
• DOI: 10.1097/00000539-199905000-00005

Hextend[registered sign] (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, two-center study (n = 120), we compared the efficacy and safety of Hextend[registered sign] 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. Hextend[registered sign] was as effective as HES for the treatment of hypovolemia. Patients received an average of 1596 mL of Hextend[registered sign]42% received >20 mL/kg up to a total of 5000 mL. No patient received albumin. Hextend[registered sign]-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 = 56; 47%), Hextend[registered sign]-treated patients had a lower mean estimated blood loss (956 mL less; P = 0.02) and were less likely to receive calcium supplementation (P = 0.04). Patients receiving HES demonstrated significant prolongation of time to onset of clot formation (based on TEG) not seen in the Hextend[registered sign] patients (P < 0.05). No Hextend[registered sign] 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 Hextend[registered sign], 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. ImplicationsHextend[registered sign] (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.(Anesth Analg 1999;88:992-8)