Phase 4
Completed N=177
Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery
Source: ClinicalTrials.gov NCT00958581 ↗Enrolled (actual)
177
Serious AEs
1.7%
Results posted
Dec 2017
Primary outcomePrimary: Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) — 1775; 2116; 1531 ml
◆ Published Evidence
Established
65citations · ~4 / year
A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery.
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.
Linked Publications
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A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery.
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 |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00958581) and the linked publication. 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. Informational only — not medical advice.