From the Division of Trauma, Acute Care and Critical Care Surgery, Department of Surgery (M.L.D., J.S.O., S.B.A.), Department of Comparative Medicine (J.M.I.), Penn State University College of Medicine; Department of Public Health Sciences (A.R.K.), Penn State University; and Department of Agricultural and Biological Engineering (K.C., C.C., J.M.C.), Penn State University Colleges of Agricultural Sciences and Engineering, Hershey, Pennsylvania.
J Trauma Acute Care Surg. 2023 Nov 1;95(5):672-678. doi: 10.1097/TA.0000000000004106. Epub 2023 Jul 21.
Uncontrolled hemorrhage is the leading cause of preventable death in combat and civilian trauma. Efficacious hemostatic agents in junctional hemorrhage can quell blood loss and improve survival. We hypothesized that a novel hemostatic foam of starch and chitosan would improve hemostasis, and thereby increase survival in a swine femoral artery hemorrhage model when compared with CombatGauze (CG).
A novel hemostatic foam of starch and chitosan was created and modified during the study period. Thirty pigs (four excluded) were assigned to treatment using either foam version 1 (FV1, n = 9) or 2 (FV2, n = 8), or (n = 9) in a standard swine femoral artery hemorrhage model. Animals were observed for 150 minutes. Outcomes assessed included hemostasis, survival, posttreatment blood loss, IV fluid volume, and hemodynamic and laboratory trends.
Hemostasis prior to 150 minutes was similar with 44.4%, 77.8%, and 50% of swine treated with CG, FV1 and FV2, respectively (Kaplan-Meyer and log-rank test [KM-LR] p > 0.05). Survival to 150 minutes was improved in swine treated with FV1 (100%) compared with CG (55.6%) (KM-LR p = 0.02). Survival was similar between FV1 and FV2 (75%) (KM-LR p > 0.05), and between CG and FV2 (KM-LR p > 0.05). Using mixed model for longitudinal data, mean arterial pressure decreased significantly in CG- and FV2-treated swine, while there was no significant change in mean arterial pressure in FV1-treated swine. Trends in lactic acid, hematocrit, platelets, INR, and thrombelastography were more favorable for FV1 compared with CG.
In this preclinical study of junctional hemorrhage, survival was improved in swine treated with version 1 of a novel chitosan/starch foam compared with CG. Trends in hemodynamics and laboratory data were also more favorable in the FV1-treated swine. This novel hemostatic foam may be an effective alternative to current hemostatic agents.
在战斗和民用创伤中,无法控制的出血是可预防死亡的主要原因。在联合出血中有效的止血剂可以控制失血并提高存活率。我们假设一种新型的淀粉和壳聚糖止血泡沫会比 CombatGauze(CG)更有效地止血,从而提高在猪股动脉出血模型中的存活率。
在研究期间,创建并修改了一种新型的淀粉和壳聚糖止血泡沫。将 30 头猪(4 头除外)分配到使用泡沫版本 1(FV1,n = 9)或 2(FV2,n = 8)的治疗中,或在标准的猪股动脉出血模型中(n = 9)。动物观察 150 分钟。评估的结果包括止血、存活率、治疗后失血、IV 液体积以及血流动力学和实验室趋势。
在 150 分钟之前,用 CG、FV1 和 FV2 治疗的猪的止血率分别为 44.4%、77.8%和 50%,相似(Kaplan-Meier 和对数秩检验[KM-LR]p>0.05)。用 FV1 治疗的猪的存活率提高到 150 分钟时为 100%,而 CG 为 55.6%(KM-LR p = 0.02)。FV1 和 FV2 之间的存活率相似(KM-LR p>0.05),CG 和 FV2 之间的存活率也相似(KM-LR p>0.05)。使用纵向数据的混合模型,CG 和 FV2 治疗的猪的平均动脉压显著下降,而 FV1 治疗的猪的平均动脉压没有明显变化。FV1 与 CG 相比,乳酸、血细胞比容、血小板、INR 和血栓弹性图的趋势更有利。
在本项联合出血的临床前研究中,与 CG 相比,新型壳聚糖/淀粉泡沫版本 1 治疗的猪的存活率提高。FV1 治疗的猪的血流动力学和实验室数据的趋势也更有利。这种新型止血泡沫可能是当前止血剂的有效替代品。