Status:
COMPLETED
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Scoliosis
Kyphosis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 bloo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00320619
Start Date
September 1 2000
End Date
February 1 2006
Last Update
July 29 2016
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287