Aminocaproic Acid and Bleeding in Spinal Surgery

描述（由申请人提供）： 候选人肖恩·贝伦霍尔茨是约翰霍普金斯大学的教员， 成人重症监护医学部（CCM）， 麻醉学/CCM。他的目标是成为一名独立的临床科学家 专注于将严格的研究设计应用于质量改进， 重症监护病房，重点是评估同种异体移植的替代方案 危重病人输血。为了实现这一目标，他将 参加临床研究的正式高级学位课程， 将接受高级调查员的系统指导， 有监督的创新研究的具体目标和相关假设 本研究的主要内容为：1.确定术前患者或医院 预测成人患者同种异体输血的特征 从1997年到2000年在马里兰州接受脊柱手术。我们将分析 非联邦急症护理医院成人患者的出院数据 在马里兰州，从1997年到1999年， 2000年（n=3988）。我们假设术前患者的特征， 包括高龄和心脏病的存在， 同种异体输血的发生率增加。2.确定 同种异体输血与临床及经济的关系 在约翰霍普金斯医院进行大容量手术后的结果。我们将 对约翰霍普金斯出院的数据进行前瞻性审查 数据库我们假设，异基因输血次数的增加与肿瘤发生率的增加之间存在剂量反应关系。 术后并发症，包括院内感染，ICU长度 住院费和住院费。3.评估药物的有效性和安全性 氨基己酸（EACA）减少同种异体输血需求 在约翰霍普金斯医院接受脊柱手术的170名患者中。我们将 在170名患者中进行EACA与安慰剂的随机对照试验 接受脊柱手术，我们已经完成了一项试点研究， 这种做法的可行性。我们假设接受EACA的患者 需要的异体输血量比接受 安慰剂4.评估EACA对经济成果的影响，包括 住院时间（LOS）和患者住院护理的直接费用 在约翰霍普金斯医院接受脊柱手术。我们假设EACA的直接成本低于对照组。完成 这项拟议中的研究将大大推进我们对谁是 可能需要同种异体输血，与之相关的并发症 输血和减少输血暴露的策略。这些项目 所描述的职业发展计划将为 作为独立调查员的成功职业生涯。

DESCRIPTION (provided by applicant): The candidate, Sean Berenholtz, is on the faculty at Johns Hopkins University, in the Division of Adult Critical Care Medicine (CCM), Department of Anesthesiology/CCM. His goal is to become an independent clinician scientist focused on applying rigorous research design to quality improvement in the intensive care unit, with an emphasis on evaluating alternatives to allogeneic blood transfusion in critically ill patients. To realize this goal, he will enroll in a formal advanced degree program in clinical investigation and he will receive structured mentoring by senior investigators for the conduct of supervised, innovative research. The specific aims and related hypothesis of the proposed research are: 1. To identify preoperative patient or hospital characteristics that predict allogeneic transfusion in adult patients undergoing spine surgery in Maryland from 1997 to 2000. We will analyze hospital discharge data for adult patients in non-federal acute care hospitals in Maryland who had a primary procedure code for spine surgery from 1997 to 2000 (n=3988). We hypothesize that preoperative patient characteristics, including advanced age and the presence of cardiac disease, are associated with an increased incidence of allogeneic transfusion. 2. To determine the association of allogeneic blood transfusion with clinical and economic outcomes following high-volume surgeries at Johns Hopkins Hospital. We will conduct a prospective review of data from the Johns Hopkins discharge database. We hypothesize that there is a dose-response association between anincreased number of allogeneic transfusions and an increased incidence of postoperative complications, including nosocomial infections, ICU length of stay, and hospital costs. 3. Assess the efficacy and safety of epsilon aminocaproic acid (EACA) in reducing allogeneic blood transfusion requirements in 170 patients undergoing spine surgery at Johns Hopkins Hospital. We will conduct a randomized controlled trial of EACA versus placebo in 170 patients undergoing spine surgery and we have completed a pilot study demonstrating the feasibility of this approach. We hypothesize that patients receiving EACA will require 30% fewer allogeneic blood transfusions than patients receiving placebo. 4. Evaluate the impact 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. We hypothesize that thedirect costs of EACA are less than those in the control group. Completion of the proposed research will significantly advance our knowledge of who is likely to require allogeneic transfusion, the complications associated with transfusion, and strategies to reduce transfusion exposure. These projects and the career development plan described will build a foundation for a successful career as an independent investigator.