Phase 4 N=177 Randomized Triple-blind Treatment

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

Scoliosis

Bottom Line

View on ClinicalTrials.gov: NCT00958581 ↗

Enrolled (actual)

177

Serious AEs

1.7%

Results posted

Dec 2017

Primary outcome: Primary: Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) — 1775; 2116; 1531 ml

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tranexamic Acid (Drug); Normal Saline (Drug); Epsilon aminocaproic acid (Drug)
Age: Pediatric, Adult, Older Adult · 10+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)	1775; 2116; 1531	—
SECONDARY Total Units of Autologous and Allogenic Transfusion (Both Intraoperatively and Postoperatively Until Discharge)	—	—
SECONDARY Length of Hospital Stay From Admission Until Patient Discharge	—	—

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 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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00958581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.