title: Efficacy of a prehospital self-expanding polyurethane foam for noncompressible hemorrhage under extreme operational conditions.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Adam P
authors.initials: AP
authors.lastname: Rago
authors.forename: Andreas
authors.initials: A
authors.lastname: Larentzakis
authors.forename: John
authors.initials: J
authors.lastname: Marini
authors.forename: Abby
authors.initials: A
authors.lastname: Picard
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Duggan
authors.forename: Rany
authors.initials: R
authors.lastname: Busold
authors.forename: Marc
authors.initials: M
authors.lastname: Helmick
authors.forename: Greg
authors.initials: G
authors.lastname: Zugates
authors.forename: John
authors.initials: J
authors.lastname: Beagle
authors.forename: Upma
authors.initials: U
authors.lastname: Sharma
authors.forename: David R
authors.initials: DR
authors.lastname: King
mesh_terms: D000007:Abdominal Injuries / Q000150:complications*; D000818:Animals; D004638:Emergency Treatment; D006470:Hemorrhage / Q000209:etiology* / Q000517:prevention & control*; D006489:Hemostatic Techniques; D006490:Hemostatics / Q000494:pharmacology*; D008887:Military Medicine; D011140:Polyurethanes / Q000494:pharmacology*; D015203:Reproducibility of Results; D013552:Swine
chemical_list: D006490:Hemostatics; D011140:Polyurethanes; C028279:polyurethane foam