AMINOCAPROIC ACID AND BLEEDING IN SPINAL SURGERY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。骨科手术，特别是脊柱手术，可伴有大量失血量，需要异体输血。同种异体输血与发病率和费用增加有关。抗纤溶药物由于其安全性和易于给药，是减少输血的一种有吸引力的策略。本研究计划的主要目的是确定epsilon氨基己酸（EACA）是否是一种安全有效的策略，以降低182名接受脊柱手术的成人患者与异基因输血相关的发病率和成本。目的1：评估EACA在减少182例约翰霍普金斯医院脊柱手术患者异体输血需求中的有效性和安全性。为了实现我们的目标，我们将在182例选择性脊柱融合术患者中进行EACA与安慰剂的随机、双盲、对照试验。约翰霍普金斯医院植骨椎体融合术植骨和/或内固定手术（ICD-0-CM 754.2）。我们假设接受EACA的患者比接受安慰剂的患者需要少30%的异体输血，而不会增加血栓并发症。如果EACA是一种有效的策略来减少接受脊柱手术的成人患者的异体输血需求，那么患者暴露和与异体输血相关的风险将会降低。目标2：评估EACA对经济结果的影响，包括在约翰霍普金斯医院接受脊柱手术的患者的住院时间（LOS）和医院护理的直接成本。为了达到我们的目的，我们将比较干预组和对照组的直接医疗费用。我们假设EACA的直接成本低于对照组。这是一项重要的研究，因为医院护理的成本越来越受到关注。需要对新疗法进行经济评估，例如我们提出的在脊柱手术患者中使用epsilon氨基己酸的试验。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Orthopedic surgery, particularly spine surgery, can be associated with dramatic blood loss requiring allogeneic blood transfusions. Allogeneic transfusion is associated with morbidity and increased costs. Because of their safety and ease of administration, antifbrinolystic drugs represent an attractive strategy to reduce transfusions. The primary goals of this research proposal is to determine whether epsilon aminocaproic acid (EACA) is a safe and effective strategy to reduce the morbidity and costs associated with allogeneic blood transfusion in 182 adult patients undergoing spine surgery. The specific aims and related hypothesis are: AIM 1: Assess the efficacy and safety of EACA in reducing allogeneic blood transfusion requirements in 182 patients undergoing spine surgery at Johns Hopkins Hospital. To accomplish our aim, we will conduct a randomized, double masked, controlled trial of EACA versus placedbo in 182 patients undergoing elective spinal fusion. Arthrodesis of spine with bone graft bone graft, and/or internal fixation surgery (ICD-0-CM 754.2) at Johns Hopkins Hospital. We hypothesize that patients receiving EACA will require 30% fewer allogeneic transfusions than patients receiving placebo without an increase in thrombotic complication. If EACA is an effective strategy to reduce allogeneic transfusions requirements in adult patients undergoing spine surgery, patient exposure and the risks associated with allogeneic blood transfusion would be decreased. AIM 2: Evaluate the impactr of EACA on economic outcomes, including hospital length of stay (LOS) and direct costs of hospital care in patients undergoing spine surgery at Johns Hopkins Hospital. To accomplish our aim, we will compare the direct costs of medical care in the intervention group versus those in the control group. We hypothesize that the direct costs of EACA are less than those in the control group. This is an important study because the costs of hospital care are increasingly scrutinized. necessitating the economic evaluation of novel therapies such as our proposed trial of epsilon aminocaproic acid in patients undergoing spine surgery.