Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery

Completed · Phase 4 · Has a placebo group

Conditions studied: Scoliosis

In brief

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 orthopedic surgery literature. In a randomized, double-blind, prospective study we believe that TXA will be more effective than both EACA and placebo at reducing blood loss for corrective spinal surgery.

Key facts

Study ID

NCT00958581

Run by

NYU Langone Health

People needed

177

Starts

2008-12-01

Expected to finish

2012-09-01

Last updated by the study team

2018-01-17

Who can join

Age: 10 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine - Department of Orthopaedic Surgery - Spine — New York, New York, United States

Full record on ClinicalTrials.gov

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