跳至主要内容
临床试验/NCT01391182
NCT01391182已完成不适用

Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
60
试验地点
2
主要终点
Hemoglobin levels and transfusion rates.

研究概览

简要总结

You are being asked to take part in this research study because you are scheduled to have total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA to prevent bleeding during and after surgery; use of this drug as a means of preventing bleeding is not currently approved by the FDA.

详细描述

The goal of this prospective randomized study is to evaluate the effectiveness of a drug, epsilon aminocaproic acid (EACA), in reducing the frequency of postoperative blood transfusion following primary total hip arthroplasty. In our institution, up to 40% of patients with a preoperative of 13.5 g/dl or less undergoing total hip arthroplasty will require a blood transfusion. Fibrinolytic drugs such as EACA and tranexamic acid (TA) have been shown to decrease blood loss during surgery and decrease the likelihood of blood transfusion during postoperative hospitalization.. Both drugs decrease the body's ability to break down a blood clot, thus pushing the balance of blood clot formation and breakdown towards clot formation. This mechanism can decrease the amount of blood loss during and after a surgical procedure. The haemostatic effect of EACA has been investigated in multiple studies with the majority showing a positive effect on postoperative hemoglobin levels and decreased blood transfusion rates. Though several studies exist revealing the effective and safe use of perioperative TA, a similar drug to EACA, there is a paucity of information on the use of EACA in total joint arthroplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for a primary total hip arthroplasty to be performed at the Mayo Clinic
  • A preoperative hemoglobin between 10.0 and 13.5

排除标准

  • A preoperative hemoglobin less than 10.0 or greater than 13.5
  • Revision arthroplasty;
  • Arthroplasty performed for acute fracture
  • Inability to obtain informed consent;
  • Allergy to EACA
  • History of coronary stenting < 6 months
  • Heart valve replacement;
  • Renal disease,
  • Coagulopathy, DIC,
  • embolic stroke

结局指标

主要结局

Hemoglobin levels and transfusion rates.

时间窗: 96 hours after total hip arthroplasty surgery.

Postoperative hemogloblins will be monitored on postop day 1, 2, and 3.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary O'Connor

Chair, Department of Orthopedic Surgery

Mayo Clinic

研究点 (2)

Loading locations...

相似试验

Epsilon Aminocaproic Acid (EACA) for the Reduction... | 临床试验