Status:
COMPLETED
Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery
Lead Sponsor:
NYU Langone Health
Conditions:
Scoliosis
Eligibility:
All Genders
10-80 years
Phase:
PHASE4
Brief Summary
Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood loss in the cardiac surgery literature but they have not been reported in use head-to-head in the orthoped...
Detailed Description
Study Design The study is designed as a prospective, randomized, double-blinded control trial. The patient, researcher, surgeon, and anesthesiologist will all be blinded to the patient's treatment. Pa...
Eligibility Criteria
Inclusion
- Undergoing thoracic and/or lumbar surgery for correction of adolescent idiopathic scoliosis, neuromuscular scoliosis, or adult deformity for correction of condition via posterior spinal fusion of 6 levels or greater.
Exclusion
- No renal dysfunction identified by elevated blood urea nitrogen (BUN) and creatinine (CR) or BUN to CR ratio greater than 20:1
- Hold religious and/or other beliefs limiting blood transfusion
- Currently use anti-coagulant medication or have past medical history leading to abnormal coagulation profile pre-operatively
- Significant past medical history preventing the use of TXA or EACA described in the protocol
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00958581
Start Date
December 1 2008
End Date
September 1 2012
Last Update
January 17 2018
Active Locations (1)
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1
New York University School of Medicine - Department of Orthopaedic Surgery - Spine
New York, New York, United States, 10016