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Hextend, a physiologically balanced plasma expander for large volume use in major surgery: a randomized phase III clinical trial. Hextend Study Group.

Publication ,  Journal Article
Gan, TJ; Bennett-Guerrero, E; Phillips-Bute, B; Wakeling, H; Moskowitz, DM; Olufolabi, Y; Konstadt, SN; Bradford, C; Glass, PS; Machin, SJ; Mythen, MG
Published in: Anesth Analg
May 1999

UNLABELLED: Hextend (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 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 was as effective as HES for the treatment of hypovolemia. Patients received an average of 1596 mL of Hextend: 42% received >20 mL/kg up to a total of 5000 mL. No patient received albumin. Hextend-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-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 patients (P < 0.05). No Hextend 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, 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: Hextend (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.

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Published In

Anesth Analg

DOI

ISSN

0003-2999

Publication Date

May 1999

Volume

88

Issue

5

Start / End Page

992 / 998

Location

United States

Related Subject Headings

  • Surgical Procedures, Operative
  • Prospective Studies
  • Middle Aged
  • Male
  • Hydroxyethyl Starch Derivatives
  • Humans
  • Hemodynamics
  • Female
  • Double-Blind Method
  • Blood Substitutes
 

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Gan, T. J., Bennett-Guerrero, E., Phillips-Bute, B., Wakeling, H., Moskowitz, D. M., Olufolabi, Y., … Mythen, M. G. (1999). Hextend, a physiologically balanced plasma expander for large volume use in major surgery: a randomized phase III clinical trial. Hextend Study Group. Anesth Analg, 88(5), 992–998. https://doi.org/10.1097/00000539-199905000-00005
Gan, T. J., E. Bennett-Guerrero, B. Phillips-Bute, H. Wakeling, D. M. Moskowitz, Y. Olufolabi, S. N. Konstadt, et al. “Hextend, a physiologically balanced plasma expander for large volume use in major surgery: a randomized phase III clinical trial. Hextend Study Group.Anesth Analg 88, no. 5 (May 1999): 992–98. https://doi.org/10.1097/00000539-199905000-00005.
Gan TJ, Bennett-Guerrero E, Phillips-Bute B, Wakeling H, Moskowitz DM, Olufolabi Y, et al. Hextend, a physiologically balanced plasma expander for large volume use in major surgery: a randomized phase III clinical trial. Hextend Study Group. Anesth Analg. 1999 May;88(5):992–8.
Gan, T. J., et al. “Hextend, a physiologically balanced plasma expander for large volume use in major surgery: a randomized phase III clinical trial. Hextend Study Group.Anesth Analg, vol. 88, no. 5, May 1999, pp. 992–98. Pubmed, doi:10.1097/00000539-199905000-00005.
Gan TJ, Bennett-Guerrero E, Phillips-Bute B, Wakeling H, Moskowitz DM, Olufolabi Y, Konstadt SN, Bradford C, Glass PS, Machin SJ, Mythen MG. Hextend, a physiologically balanced plasma expander for large volume use in major surgery: a randomized phase III clinical trial. Hextend Study Group. Anesth Analg. 1999 May;88(5):992–998.

Published In

Anesth Analg

DOI

ISSN

0003-2999

Publication Date

May 1999

Volume

88

Issue

5

Start / End Page

992 / 998

Location

United States

Related Subject Headings

  • Surgical Procedures, Operative
  • Prospective Studies
  • Middle Aged
  • Male
  • Hydroxyethyl Starch Derivatives
  • Humans
  • Hemodynamics
  • Female
  • Double-Blind Method
  • Blood Substitutes