Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
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.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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

 -  Pregnant