Phase 3
Completed N=52
Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
Source: ClinicalTrials.gov NCT02053363 ↗Enrolled (actual)
52
Serious AEs
9.6%
Results posted
Jun 2022
Primary outcomePrimary: Blood Loss — 2046; 1596 mL
◆ Published Evidence
Emerging
10citations · ~3 / year
Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery.
Summary
The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.
Linked Publications
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Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Loss |
2046; 1596 | — |
| SECONDARY Red Blood Cell Transfusions |
1259; 935 | — |
| SECONDARY Number of Patients Sustaining Intraoperative or 90 Day Complications |
2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients (ages 18-75) scheduled to undergo long segment (greater than 8 motion segments) posterior spinal fusion with instrumentation (PSF) for adult scoliosis
Exclusion Criteria
- Patients with acquired defective color vision
- Subarachnoid hemorrhage
- Active intravascular clotting
- Hypersensitivity to tranexamic acid or any of the ingredients
- Patients who pre-donate autologous blood for intra- or post-operative use (Directed donor units are acceptable)
- History of suspected blood disorders or abnormal coagulation laboratory results
- Current anticoagulation therapy that cannot be interrupted
- History of deep vein thrombosis (DVT)
- Impaired renal function or creatinine clearance <60 ml/min
- Pregnancy or women who are lactating/breastfeeding
- Women on hormonal contraceptives
Data sourced from ClinicalTrials.gov (NCT02053363) 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.