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

Condition(s) targeted: Scoliosis; Kyphosis; Lordosis; Spondylitis; Spinal Stenosis

Intervention: Epsilon-Aminocaproic Acid (EACA) (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

Official(s) and/or principal investigator(s):
Sean Berenholtz, MD, MHS, Principal Investigator, Affiliation: Johns Hopkins Medical Institutions

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.

Official title: Aminocaproic Acid and Bleeding in Spinal Surgery

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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)

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Johns Hopkins Hospital, Baltimore, Maryland 21287, United States

Related publications:

Goodnough LT, Bach RG. Anemia, transfusion, and mortality. N Engl J Med. 2001 Oct 25;345(17):1272-4. No abstract available.

Troianos CA, Sypula RW, Lucas DM, D'Amico F, Mathie TB, Desai M, Pasqual RT, Pellegrini RV, Newfeld ML. The effect of prophylactic epsilon-aminocaproic acid on bleeding, transfusions, platelet function, and fibrinolysis during coronary artery bypass grafting. Anesthesiology. 1999 Aug;91(2):430-5.

Slaughter TF, Faghih F, Greenberg CS, Leslie JB, Sladen RN. The effects of epsilon-aminocaproic acid on fibrinolysis and thrombin generation during cardiac surgery. Anesth Analg. 1997 Dec;85(6):1221-6.

Florentino-Pineda I, Thompson GH, Poe-Kochert C, Huang RP, Haber LL, Blakemore LC. The effect of amicar on perioperative blood loss in idiopathic scoliosis: the results of a prospective, randomized double-blind study. Spine. 2004 Feb 1;29(3):233-8.

Starting date: September 2000
Ending date: February 2006
Last updated: April 30, 2007