From the Department of Surgery, Division of Trauma, Emergency Surgery and Surgical Critical Care, Massachusetts General Hospital/Harvard Medical School, Boston, MA (D.R.K., J.O.H., A.E.E., M.J.D.); Department of Surgery, Division of Trauma, Emergency Surgery and Surgical Critical Care, Massachusetts General Hospital/Harvard Medical School, Boston, MA & Emergency and Traumatology Department (Q.P.P., S.G., M.F., U.S.), Tanta University, Egypt (A.I.E.); and Arsenal Medical, Inc., Waltham, MA.
J Trauma Acute Care Surg. 2024 May 1;96(5):727-734. doi: 10.1097/TA.0000000000004138. Epub 2023 Sep 13.
Mortality for pelvic fracture patients presenting with hemorrhagic shock ranges from 21% to 57%. The objective of this study was to develop a lethal and clinically relevant pelvic hemorrhage animal model with and without bony fracture for evaluating therapeutic interventions. ResQFoam is a self-expanding foam that has previously been described to significantly decrease mortality in large-animal models of abdominal exsanguination. We hypothesized that administration of ResQFoam into the preperitoneal space could decrease mortality in exsanguinating pelvic hemorrhage.
Two pelvic hemorrhage models were developed using noncoagulopathic swine. Pelvic hemorrhage model 1: bilateral, closed-cavity, major vascular retroperitoneal hemorrhage without bony pelvic fracture. After injury, animals received no treatment (control, n = 10), underwent preperitoneal packing using laparotomy pads (n = 11), or received ResQFoam (n = 10) injected into the preperitoneal space. Pelvic hemorrhage model 2: unilateral, closed-cavity, retroperitoneal hemorrhage injury (with intraperitoneal communication) combined with complex pelvic fracture. After injury, animals received resuscitation (control, n = 12), resuscitation with preperitoneal packing (n = 10) or with ResQFoam injection (n = 10) into the preperitoneal space.
For model 1, only ResQFoam provided a significant survival benefit. The median survival times were 50 minutes and 67 minutes for preperitoneal packing and ResQFoam, compared with 6 minutes with controls ( p = 0.002 and 0.057, respectively). Foam treatment facilitated hemodynamic stabilization and resulted in significantly less hemorrhage (21.5 ± 5.3 g/kg) relative to controls (31.6 ± 5.0 g/kg, p < 0.001) and preperitoneal packing (32.7 ± 5.4 g/kg, p < 0.001). For model 2, both ResQFoam and preperitoneal packing resulted in significant survival benefit compared with controls. The median survival times were 119 minutes and 124 minutes for the preperitoneal packing and ResQFoam groups, compared with 4 minutes with controls ( p = 0.004 and 0.013, respectively).
Percutaneous injection of ResQFoam into the preperitoneal space improved survival relative to controls, and similar survival benefit was achieved compared with standard preperitoneal pelvic packing. The technology has potential to augment the armamentarium of tools to treat pelvic hemorrhage.
骨盆骨折伴出血性休克患者的死亡率为 21%至 57%。本研究的目的是建立一种致命且具有临床相关性的骨盆出血动物模型,包括有和无骨骨折,以评估治疗干预措施。ResQFoam 是一种自膨胀泡沫,先前已被证明可显著降低大型动物腹部出血模型的死亡率。我们假设将 ResQFoam 注入腹膜前间隙可降低失血性骨盆出血的死亡率。
使用非凝血性猪建立了两种骨盆出血模型。骨盆出血模型 1:双侧、封闭腔、主要血管腹膜后出血,无骨盆骨折。损伤后,动物未接受任何治疗(对照组,n=10)、接受剖腹术垫进行腹膜前填塞(n=11)或接受 ResQFoam(n=10)注入腹膜前间隙。骨盆出血模型 2:单侧、封闭腔、腹膜后出血损伤(伴有腹腔内沟通)合并复杂骨盆骨折。损伤后,动物接受复苏(对照组,n=12)、腹膜前填塞复苏(n=10)或 ResQFoam 注射(n=10)到腹膜前间隙。
对于模型 1,只有 ResQFoam 提供了显著的生存获益。腹膜前填塞和 ResQFoam 的中位生存时间分别为 50 分钟和 67 分钟,而对照组为 6 分钟(p=0.002 和 0.057)。泡沫治疗促进了血流动力学稳定,并导致出血量明显减少(21.5±5.3 g/kg),与对照组(31.6±5.0 g/kg,p<0.001)和腹膜前填塞(32.7±5.4 g/kg,p<0.001)相比。对于模型 2,ResQFoam 和腹膜前填塞均与对照组相比具有显著的生存获益。腹膜前填塞和 ResQFoam 组的中位生存时间分别为 119 分钟和 124 分钟,而对照组为 4 分钟(p=0.004 和 0.013)。
经皮将 ResQFoam 注入腹膜前间隙可提高与对照组相比的生存率,并且与标准的腹膜前骨盆填塞相比,生存率相似。该技术有可能增加治疗骨盆出血的工具包。