Phase 3
N=52
Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
Adult Spinal Deformity
Bottom Line
View on ClinicalTrials.gov: NCT02053363 ↗Enrolled (actual)
52
Serious AEs
9.6%
Results posted
Jun 2022
Primary outcome: Primary: Blood Loss — 2046; 1596 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic Acid (Cyklokapron) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2020
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 | — |
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.
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). 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.