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临床试验/NCT00320619
NCT00320619已完成不适用

Aminocaproic Acid and Bleeding in Spinal Surgery

National Heart, Lung, and Blood Institute (NHLBI)1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2000年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
1
主要终点
Number of allogenic blood units transfused

研究概览

简要总结

Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.

详细描述

Spine surgery is often required to correct a number of diseases, including spondylosis, pseudoarthrosis, scoliosis, or other spinal deformities. Spine surgery is often associated with significant blood loss and individuals may require multiple blood transfusions during and following surgery. Blood transfusions are expensive and carry an increased risk of health complications, including fever, allergic reactions, or infections. Preliminary research has shown that EACA may be beneficial for individuals undergoing spine surgery. In addition, EACA appears to be safer and less expensive than other medications typically used to treat serious bleeding. The purpose of this study is to evaluate the safety and effectiveness of EACA at reducing the number of blood transfusions required during and following spine surgery in adults.

This study will enroll individuals who are undergoing spine surgery at Johns Hopkins Hospital. Prior to surgery, participants' demographic data and medical history will be collected. Participants will then be randomly assigned to receive either EACA or placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU). While in the hospital, participants will have blood drawn frequently for laboratory testing. They will receive blood transfusions as needed and will be closely monitored for blood loss and any medical, surgical, or transfusion complications. Outcome measurements related to the amount of transfused blood required and postoperative complications will be collected on the 8th day following surgery. Study participation will end on the day of hospital discharge or the day of a necessary second surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, 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

  • Diagnosis of spondylosis, pseudoarthrosis, kyphoscoliosis, or acquired or congenital spine deformity
  • Willing to undergo elective spinal surgery by a participating surgeon; eligible procedures include the following: spine osteotomy, arthrodesis, instrumentation and/or corpectomy, surgery for lumbar spinal stenosis, or surgery for degenerative disc disease

排除标准

  • Requires urgent or emergent surgery
  • Has kidney failure that requires dialysis
  • Has a known bleeding diathesis, defined as a documented history of an inherited bleeding disorder (e.g., hemophilia or von Willebrand's disease) OR prothrombin time ratio greater than 1.5 seconds OR a documented previous arterial or venous thrombosis within 1 year of study entry

研究组 & 干预措施

1

Experimental

Participants will receive either EACA.

干预措施: Epsilon-Aminocaproic Acid (EACA) (Drug)

2

Placebo Comparator

Participants will receive placebo.

干预措施: Placebo (Drug)

结局指标

主要结局

Number of allogenic blood units transfused

时间窗: Measured through the 8th postoperative day

次要结局

  • ICU length of stay (LOS)(Measured through the 8th postoperative day)
  • Hospital LOS(Measured through the 8th postoperative day)
  • Direct costs of hospital care(Measured through the 8th postoperative day)
  • Potential complications of EACA(Measured through the 8th postoperative day)
  • Potential surgical complications(Measured through the 8th postoperative day)
  • Duration of mechanical ventilation(Measured through the 8th postoperative day)
  • In-hospital mortality(Measured through the 8th postoperative day)
  • Intraoperative and postoperative blood loss(Measured through the 8th postoperative day)
  • Intraoperative and postoperative blood products received, including autologous blood, allogenic blood, fresh frozen plasma, platelets, or cryo(Measured through the 8th postoperative day)
  • Potential complications of transfusion(Measured through the 8th postoperative day)

研究者

研究点 (1)

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