AMINOCAPROIC ACID AND BLEEDING IN SPINAL SURGERY

这个子项目是众多研究子项目之一

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.