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National Heart, Lung, and Blood Institute (NHLBI) and Food and Drug Administration (FDA) Public Workshop: Risks and Benefits of Hydroxyethyl Starch Solutions
September 6-7, 2012 National Institutes of Health Bethesda, MD
Executive Summary FINAL DRAFT
The workshop on the Risks and Benefits of Hydroxyethyl Starch Solutions (HES) was convened on September 6-7, 2012. Experts from the National Institutes of Health (NIH), Department of Defense (DoD), U.S. Food and Drug Administration (FDA), Department of Veterans Affairs (VA), academia, and industry attended the workshop to discuss new findings on the risks and benefits of FDA-approved HES, as well as the barriers to the development and use of resuscitation fluids in general. The purpose was to aid in planning future clinical studies in this area. Key areas discussed were the:
HES are synthetic colloids composed almost entirely of amylopectin obtained from corn or potatoes. They are licensed as plasma volume expanders for the treatment of hypovolemic shock due to sepsis, acute hemorrhage (trauma), and burns. HES vary in their molecular weight, hydroxyethyl moieties, and in the ratio of C2 to C6 substitutions. Although a causal relationship has not been firmly established, large volumes of HES used in resuscitation may dilute plasma proteins and are associated with coagulation abnormalities that cannot be attributed solely to hemodilution and result in bleeding and/or anemia with possible compromised platelet function.
In reviewing the relevant basic and clinical science, including clinical research studies focusing on the incidence of related adverse events associated with the use of HES, the workshop participants noted that there have been many published clinical studies and trials using HES as a resuscitation fluid over the past 25 years. These studies have demonstrated no clear benefits of HES over other available IV resuscitation solutions with respect to risks for increased bleeding and renal toxicity. In addition, these studies have generally lacked a good definition of hypovolemia and information regarding bleeding characteristics. Two very large recently completed randomized trials (6S and CHEST) conducted in patients with sepsis and hypovolemia were described and discussed. Based on the available data, the group agreed that HES behaved as a class in terms of their toxic effects on bleeding and renal failure, which means that results from studies with one HES may be extrapolated to other HESs. They believed that studies performed with HES in elective surgery suggest some benefit, but harm was not ruled out because follow-up of patients was too short. Although some participants suggested that HES studies in elective surgery patients with long-term follow-up could be helpful in identifying long-term risks and benefits, others indicated that these did not warrant public funding. The group believed that these fluids are frequently overused in potentially hypovolemic conditions.
The Workshop Steering Committee plans to submit a summary of the meeting for publication in a peer-reviewed journal.
Participating Agencies, Divisions, and Institutes
Center for Biologics Evaluation and Research (CBER), FDA
Workshop Steering Committee
Other Speakers and Discussants
Last Updated: December 2012