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Efficacy of a prehospital self-expanding polyurethane foam for noncompressible hemorrhage under extreme operational conditions

Rago, Adam P. MS; Larentzakis, Andreas MD; Marini, John; Picard, Abby; Duggan, Michael J. DVM; Busold, Rany; Helmick, Marc; Zugates, Greg PhD; Beagle, John; Sharma, Upma PhD; King, David R. MD

Journal of Trauma and Acute Care Surgery: February 2015 - Volume 78 - Issue 2 - p 324–329
doi: 10.1097/TA.0000000000000507
Original Articles
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BACKGROUND: Noncompressible abdominal hemorrhage is a significant cause of battlefield and civilian mortality. We developed a self-expanding polyurethane foam intended to provide temporary hemorrhage control and enable evacuation to a definitive surgical capability, for casualties who would otherwise die. We hypothesized that foam treatment would be efficacious over a wide range of out-of-hospital operational conditions.

METHODS: The foam was tested in an established lethal, closed-cavity hepatoportal injury model in four groups as follows. Group 1 involved baseline conditions, wherein foam was deployed from a pneumatically driven, first-generation delivery device at room temperature (n = 6). Group 2 involved foam deployment from a field-relevant, handheld delivery prototype (n = 12). Group 3 involved foam components that were conditioned to simulate 1-year shelf-life (n = 6). Group 4 involved foam that was conditioned to a range of temperatures (10°C and 50°C; n = 6 per group). In all studies, survival was monitored for up to 180 minutes and compared with an ongoing and accumulating control group with no intervention (n = 14).

RESULTS: In Group 1 with a first-generation delivery system, foam treatment resulted in a significant survival advantage relative to the control group (p < 0.001), confirming previous results. In Group 2 with a handheld delivery system, survival was also improved, 83% at 3 hours, compared with 7% in the control group (p < 0.001). In Group 3, survival was 83% at 3 hours (p = 0.002). In Group 4 at temperature extremes, 3-hour survival was 83% (p = 0.002) and 67% (p = 0.014) in the low- and high-temperature groups, respectively. Temperature extremes did not result in hypothermia, hyperthermia, or thermal injury. In all studies, the bleeding rate in foam groups was significantly lower than in the control group (p < 0.05).

CONCLUSION: Under a range of military operational conditions, foam treatment resulted in a survival advantage relative to the control group. This supports the feasibility of foam treatment as a prehospital hemostatic bridge to surgery for severely bleeding causalities.

From the Division of Trauma, Emergency Surgery and Surgical Critical Care (A.L., M.J.D., J.B., D.R.K.), Department of Surgery, Massachusetts General Hospital and Harvard Medical School, Boston; and Arsenal Medical, Inc. (A.P.R., J.M., A.P., R.B., M.H., G.Z., U.S.), Watertown, Massachusetts.

Submitted: July 11, 2014, Revised: September 5, 2014, Accepted: October 2, 2014.

Address for reprints: David R. King, MD, Division of Trauma, Emergency Surgery, and Surgical Critical Care, Massachusetts General Hospital, 165 Cambridge St, Suite 810, Boston, MA 02141; email: dking3@partners.org.

© 2015 Lippincott Williams & Wilkins, Inc.