Clinical Trial: Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Aminocaproic Acid and Bleeding in Spinal Surgery

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Current Primary Outcome: Number of allogenic blood units transfused [ Time Frame: Measured through the 8th postoperative day ]

Original Primary Outcome: Number of allogenic blood units transfused (measured through the 8th postoperative day)

Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: National Heart, Lung, and Blood Institute (NHLBI)

Dates:
Date Received: April 28, 2006
Date Started: September 2000
Date Completion:
Last Updated: July 28, 2016
Last Verified: March 2009