Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following 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