Kyphosis, Lordosis, Scoliosis, Spinal Stenosis, Spondylitis
Conditions
Keywords
Aminocaproic Acids, Blood Transfusion
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.
Interventions
Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
DRUGPlacebo
Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of allogenic blood units transfused | Measured through the 8th postoperative day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Intraoperative and postoperative blood loss | 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 |
| Duration of mechanical ventilation | Measured through the 8th postoperative day |
Countries
United States
Outcome results
None listed