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

Not Applicable

Completed

• Conditions: Scoliosis; Kyphosis; Lordosis; Spondylitis; Spinal Stenosis
• Interventions: Drug: Epsilon-Aminocaproic Acid (EACA); Drug: Placebo

• Registration Number: NCT00320619
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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 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.

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2006-04-28
• Study First Submitted QC: 2006-04-28
• Study First Posted: 2006-05-03
• Status Verified: 2009-03
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Epsilon-Aminocaproic Acid (EACA)	Participants will receive either EACA.
2	Placebo	Participants will receive placebo.

Primary Outcome Measures

Name	Time	Method
Number of allogenic blood units transfused	Measured through the 8th postoperative day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States