From the Department of Surgery (K.A.G., A.J.K., A.L.L., P.W.W., B.P.), Walter Reed National Military Medical Center; Department of Surgery (J.A.M., J.D.H., B.A., D.M.B.), Uniformed Services University; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (J.A.M., J.D.H., B.A.); and Division of Vascular Surgery and Endovascular Therapy (J.M.W.), Johns Hopkins School of Medicine, Baltimore, Maryland.
J Trauma Acute Care Surg. 2023 Aug 1;95(2S Suppl 1):S144-S151. doi: 10.1097/TA.0000000000004071. Epub 2023 Jun 1.
Hemostatic dressings are used extensively in both military and civilian trauma to control lethal noncompressible hemorrhage. The ideal topical hemostatic agent would provide reliable hemostasis in patients with profound acidosis, coagulopathy, and shock. This study aimed to compare next-generation hemostatic agents against the current military standard in a translational swine model of vascular injury and coagulopathy.
Female Yorkshire swine were randomized to eight groups (total n = 63; control n = 14, per group n = 7) of hemostatic agents and included: QuikClot Combat Gauze (Teleflex, Morrisville, NC), which served as the control; BloodSTOP IX (LifeScience Plus, Mountain View, CA); Celox Rapid (Medtrade Product, Crewe, United Kingdom); ChitoSAM 100 (Sam Medical, Tualatin, OR); EVARREST Fibrin Sealant Patch (Ethicon, Raritan, NJ); TAC Wrapping Gauze (H&H Medical, Williamsburg, VA); ChitoGauze XR Pro (Tricol Biomedical, Portland, OR); and X-Stat 30 (RevMedX, Wilsonville, OR). Hemodilution via exchange transfusion of 6% hetastarch was performed to induce acidosis and coagulopathy. An arteriotomy was created, allowing 30 seconds of free bleeding followed by application of the hemostatic agent and compression via an external compression device. A total of three applications were allowed for continued/recurrent bleeding. All blood loss was collected, and hemostatic agents were weighed to calculate blood volume loss. Following a 180-minute observation period, angiography was completed to evaluate for technical complication and distal perfusion of the limb. Finally, the limb was ranged five times to assess for rebleeding and clot stability.
All swine were confirmed coagulopathic with rotational thromboelastography and acidotic (pH 7.2 ± 0.02). BloodSTOP IX allowed a significant increase in blood loss and number of applications required to obtain hemostasis compared with all other groups. BloodSTOP IX demonstrated a decreased survival rate (29%, p = 0.02). All mortalities were directly attributed to exsanguination as a result of device failure. In surviving animals, there was no difference in extravasation. BloodSTOP IX had an increased rebleeding rate after ranging compared with QuikClot Combat Gauze ( p = 0.007).
Most novel hemostatic agents demonstrated comparable efficacy compared with the currently military standard hemostatic dressing, CG.
止血敷料在军事和民用创伤中被广泛用于控制致命的非压迫性出血。理想的局部止血剂应能在酸中毒、凝血障碍和休克的患者中提供可靠的止血效果。本研究旨在通过血管损伤和凝血障碍的转化猪模型，比较下一代止血剂与当前的军用标准。
雌性约克夏猪被随机分为 8 组（总 n = 63；对照组 n = 14，每组 n = 7）的止血剂，包括：QuikClot Combat Gauze（Teleflex，Morrisville，NC），作为对照组；BloodSTOPIX（LifeScience Plus，Mountain View，CA）；Celox Rapid（Medtrade Product，Crewe，英国）；ChitoSAM100（Sam Medical，Tualatin，OR）；EVAREST 纤维蛋白密封剂贴剂（Ethicon，Raritan，NJ）；TAC 包裹纱布（H&H Medical，Williamsburg，VA）；ChitoGauze XR Pro（Tricol Biomedical，Portland，OR）；和 X-Stat30（RevMedX，Wilsonville，OR）。通过交换输血进行 6%羟乙基淀粉稀释以诱导酸中毒和凝血障碍。创建一个动脉切开术，允许 30 秒的自由出血，然后应用止血剂，并通过外部压缩装置进行压缩。允许进行总共三次应用以进行持续/复发出血。收集所有失血，并称重止血剂以计算失血量。在 180 分钟观察期后，完成血管造影术以评估技术并发症和肢体的远端灌注。最后，对肢体进行五次范围检查以评估再出血和凝块稳定性。
所有猪均通过旋转血栓弹性描记术和酸中毒（pH7.2 ± 0.02）证实为凝血障碍。与所有其他组相比，BloodSTOPIX 导致失血量显著增加，且需要更多的应用次数才能达到止血效果。BloodSTOPIX 的存活率降低（29%，p = 0.02）。所有死亡均直接归因于由于设备故障导致的失血性休克。在存活的动物中，没有外渗的差异。与 QuikClot Combat Gauze 相比，BloodSTOPIX 在范围后再出血率增加（p = 0.007）。
与当前军用标准止血剂 CG 相比，大多数新型止血剂的疗效相当。
