Scoliosis Clinical Trial
Official title:
Aminocaproic Acid and Bleeding in Spinal 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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