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

Abstract

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.

Percutaneous damage control with self-expanding foam: pre-hospital rescue from abdominal exsanguination

“…In both studies, foam treatment significantly improved survival and reduced hemorrhage rate relative to the control group. Deployment of foam conditioned to temperature extremes did not result in hypothermia, hyperthermia, or thermal injury (21). Finally, the hepatoportal injury model was modified to include full-thickness injuries in the diaphragm.…”

“…21 All testing was conducted in the hepatoportal injury model. First, foam performance was evaluated following delivery from a robust, hand-operated delivery system (Figure 4; n ¼ 12).…”

“…Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging therapy for this purpose, but this technique requires endovascular access and is associated with a variety of problematic complications. [9][10][11][12] To address the unmet need, a self-expanding polyurethane foam has been developed for the temporary treatment of massive, non-compressible abdominal exsanguination [13][14][15][16][17][18][19][20][21][22] in the pre-hospital environment. The intervention consists of two liquid precursors contained in a percutaneous delivery system.…”

Prehospital care is critical to improving outcomes after major trauma

“…After introduction into the peritoneal cavity of a patient with haemorrhage via access similar to that of a laparoscopic trocar, the foam would rapidly expand to the fill the volume of the cavity, providing tamponade to any ongoing bleeding. While fatal animal models have shown improved survival with this technique, studies in humans are still under way. Significant challenges with this concept exist, notably removing the foam at the time of laparotomy to enable swift access to bleeding structures (prolonging surgical haemostasis).…”

Massive bleeding following severe blunt trauma: the first minutes that can change everything

“…These include intraperitoneal injection of selfexpanding polyurethane polymer foam for noncompressible massive hemorrhage as well as prehospital thoracotomy, although these methods are as yet of unproven efficacy. [35][36][37] The on-going ''FI in TIC'' study will evaluate whether the prehospital pro-coagulant treatment with fibrinogen concentrate would improve plasmatic coagulation capacity in severe bleeding trauma [38] but until now there is no evidence encouraging the use of fibrinogen concentrate in massive bleeding. Regarding the prehospital administration of Prothrombin Complex Concentrate in the absence of a vitamin K antagonist therapy, data are still lacking.…”