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Hyperchloremic Acidemia Linked to Saline-Based Surgical Fluids, But Not Hextend.


BERKELEY, Calif.--(BW HealthWire)--Oct. 12, 1999--

BioTime, Inc. (AMEX AMEX

See: American Stock Exchange
:BTX (Balanced Technology EXtended) A motherboard design from Intel introduced in 2004 that supersedes the ATX. Unlike the ATX, the placement of all chip sockets in the BTX is defined in order to provide sufficient air flow over the processor and display adapter. ) announced today that a clinical trial of its plasma expander Hextend(R) in older patients showed that the primary endpoint had been met. Hyperchloremic acidemia acidemia /ac·i·de·mia/ (as?i-de´me-ah) increased acidity of the blood. For those characterized by increased concentration of a specific acid, see at the acid.  was found in surgical patients treated with saline-based surgical fluids but not in those treated with Hextend. The findings are from a preliminary analysis of the results from the prospective, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blinded, controlled clinical trial controlled clinical trial,
n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo.
.

The control group received 6% hetastarch in saline, with saline as a concomitant crystalloid crys·tal·loid
n.
A substance that in solution can pass through a semipermeable membrane and be crystallized, as distinguished from a colloid.

adj.
Resembling or having properties of a crystal or crystalloid.
, to treat blood loss during major elective surgery. Hyperchloremic metabolic acidemia was not linked to treatment with Hextend, even when it was used in large volumes (exceeding 6 liters in one patient), along with Lactated Ringer's.

The results indicated that the Hextend-treated group showed significantly better preservation of blood pH, chloride and calcium levels, compared to those treated with 6% hetastarch in saline. Hextend has been approved for the treatment of hypovolemia hypovolemia /hy·po·vo·le·mia/ (-vol-em´e-ah) diminished volume of circulating blood in the body.hypovole´mic

hy·po·vo·le·mi·a
n.
See oligemia.
, or loss of blood volume. It is the only commercially available plasma expander that contains multiple electrolytes, glucose, a physiological buffer and hetastarch. Hextend is also completely sterilized to avoid risk of infection.

Dr. Monty Mythen, the trial's leading medical investigator, said "There is now compelling evidence for using more balanced physiological solutions like Hextend when treating hypovolemia. When replacing large quantities of blood volume, fluids which are more balanced help to maintain better blood biochemistry, and acid-base balance. Furthermore, there now seems little doubt that the administration of saline-based solutions can result in patients developing metabolic hyperchloremic acidosis."

The trial, which consisted of a total of 47 patients over 60 years of age, was conducted at the prestigious University College London “UCL” redirects here. For other uses, see UCL (disambiguation).
University College London, commonly known as UCL, is the oldest multi-faculty constituent college of the University of London, one of the two original founding colleges, and the first British
 and Royal Free hospitals in the United Kingdom This article has recently been split into multiple articles entitled:
  • List of hospitals in England
  • List of hospitals in Wales
  • List of hospitals in Scotland
. BioTime will issue a complete report of the clinical trial findings after a comprehensive formal statistical analysis.

BioTime, headquartered in Berkeley, California develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, organ preservation solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant, and other applications.

The matters discussed in this press release include forward-looking statements which are subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated. Such risks and uncertainties include but are not limited to BioTime's ability to obtain foreign regulatory approval to market Hextend; competition from products manufactured and sold or being developed by other companies; the price of and demand for Hextend; the Company's ability to negotiate favorable foreign licensing or other manufacturing and marketing agreements for its products; the availability of ingredients used in Hextend; and the availability of reimbursement for the cost of Hextend (and related treatment) from government health administration authorities, private health coverage insurers and other organizations. These and other risk factors are discussed in BioTime's Annual Report on Form 10-K filed with the Securities and Exchange Commission.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 12, 1999
Words:484
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