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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Aminocaproic Acid and Bleeding in Spinal Surgery

Conditions
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Scoliosis, Kyphosis, Lordosis, Spondylitis, Spinal Stenosis

Intervention / Treatment
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* Drug: Epsilon-Aminocaproic Acid (EACA)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive either EACA. | Drug: Epsilon-Aminocaproic Acid (EACA)<br>* Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).<br>|
| Placebo Comparator: 2<br>Participants will receive placebo. | Drug: Placebo<br>* Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of allogenic blood units transfused |  | Measured through the 8th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Potential complications of EACA |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aminocaproic Acids, Blood Transfusion