Kheirabadi Bijan S, Arnaud Françoise, McCarron Richard, Murdock Alan D, Hodge Douglas L, Ritter Brandi, Dubick Michael A, Blackbourne Lorne H
US Army Institute of Surgical Research, Ft. Sam Houston, Texas, USA.
J Trauma. 2011 Jul;71(1 Suppl):S139-46. doi: 10.1097/TA.0b013e318221931e.
The diverse information of efficacy of hemostatic products, obtained from different military laboratories using different models, has made it difficult to ascertain the true benefit of new hemostatic agents in military medicine. The aim of this study was to recommend a standard hemorrhage model for efficacy testing acceptable by most investigators in the field and avoid contradictory and duplicative efforts by different laboratories.
The swine femoral artery injury model (6-mm arteriotomy) with some modifications was tested to standardize the model. The suggested modifications included no splenectomy, one-time treatment, 30 seconds free bleeding, and 5 L limit for fluid resuscitation. The model was tested with all or some of these modifications in four experimental conditions (n = 5-6 pigs per condition) using Combat Gauze (CG) as control agent.
The primary end points including blood pressure, blood loss, and survival rates were modestly changed in the four conditions. The second experimental condition in which bleeding was treated with a single CG with 3-minute compression produced the most suitable results. The average blood loss was 99 mL/kg, and hemostasis was achieved in one-third of the pigs, which led to matching survival rate.
A rigorous hemorrhage model was developed for future evaluation of new hemostatic agents and comparison with CG, the current standard of care. This model may not be suitable for testing every agent and some modifications may be necessary for specific applications. Furthermore, laboratory studies using this or similar models must be accompanied by operational testing in the field to confirm the efficacy and practical utility of selected agents when used on the battlefield.
从不同军事实验室使用不同模型获得的止血产品疗效的多样信息，使得难以确定新型止血剂在军事医学中的真正益处。本研究的目的是推荐一种大多数该领域研究人员都能接受的用于疗效测试的标准出血模型，避免不同实验室的矛盾和重复工作。
对经过一些修改的猪股动脉损伤模型（6毫米动脉切开术）进行测试以使其标准化。建议的修改包括不进行脾切除术、一次性治疗、30秒自由出血以及液体复苏的5升限制。使用战斗纱布（CG）作为对照剂，在四种实验条件下（每种条件n = 5 - 6头猪）对该模型进行全部或部分这些修改的测试。
在这四种条件下，包括血压、失血量和存活率在内的主要终点有适度变化。第二种实验条件，即使用单个CG进行3分钟压迫治疗出血，产生了最合适的结果。平均失血量为99毫升/千克，三分之一的猪实现了止血，这导致了与之匹配的存活率。
开发了一种严格的出血模型，用于未来新型止血剂的评估以及与当前护理标准CG进行比较。该模型可能不适用于测试每种药剂，对于特定应用可能需要一些修改。此外，使用此模型或类似模型的实验室研究必须伴随在实地进行的操作测试，以确认所选药剂在战场上使用时的疗效和实际效用。
