New Study Results from Use of Hextend®, BioTime, Inc. (Amex: BTIM)
Results emanated from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BTIM’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study reported that initial resuscitation with Hextend was associated with NO obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend. However, study principals cautioned that their “…study design has several limitations, but that the results are encouraging and warrant a randomized controlled clinical trial”. Results showed that overall mortality for the patients treated with Hextend was significantly lower at 5.2 % compared to 8.9 % for the patients receiving fluid resuscitation without Hextend. NO other study has evaluated the safety and efficacy specifically in trauma patients even though there had been several other studies in various other types of surgical patients.
Hextend is a formulation of 6% hetastarch combined with a physiologically balanced crystalloid carrier that more closely mirrors plasma electrolyte balance than 6% hetastarch in 0.9% sodium chloride.
- The hetastarch component creates oncotic pressure, which would normally be provided by blood proteins and permits retention of intravascular fluid,
- The crystalloid carrier provides electrolytes necessary for physiologic functions and has a composition resembling that of the principal ionic constituents of normal plasma,
- Hextend contains a normal physiological level of calcium.
The non-randomized observational trial was the largest involving Hextend in any group of surgical patients and was conducted by a team of physicians led by Kenneth G. Proctor, Ph.D. at the University of Miami Ryder Trauma Center.
- 1,714 patients were evaluated of which 805 patients received standard of care fluid resuscitation plus up to one liter of Hextend within the first 2 hours of arrival at the trauma center and 909 patients received standard of care fluid resuscitation without Hextend,
- While survival was improved in those receiving Hextend, a higher proportion of these patients required ICU admission and transfusions of blood or plasma, consistent with lower mortality and a higher percentage of patients surviving to require subsequent critical care. All results were confirmed using univariate analysis,
- Dr. Proctor’s team was one of the first to evaluate the potential use of Hextend as a resuscitation fluid in the laboratory.
The U.S. Army has deployed Hextend for initial resuscitation of battlefield casualties because less Hextend is required compared to commonly used saline solution to achieve the same plasma volume expansion effect. This offers a major logistic advantage for a combat medic who has to carry all his supplies in his backpack.
BioTime markets blood plasma volume expanders and related technology for use in surgery, emergency trauma treatment, and other applications. BTIM’s lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements.
