Phase 4
N=100
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Foot and Ankle Surgeries · Bunion
Bottom Line
View on ClinicalTrials.gov: NCT03653429 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Total Estimated Blood Loss — 40.41; 18.75 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Estimated Blood Loss |
40.41; 18.75 | — |
| SECONDARY Number of Participants With Wound Complications |
8; 8; 8; 8 | — |
| SECONDARY Intra Operative Narcotic Consumption |
93.37; 125.40 | — |
| SECONDARY Post Operative Narcotic Consumption |
6.12; 10.10 | — |
Summary
Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.
Eligibility Criteria
Inclusion Criteria
- ASA (American Society of Anesthesiology) class I-IV
- age 8-75.
Exclusion Criteria
- ASA class V
- morbid obesity
- patient refusal
- patients with known coagulopathy disorder
- renal insufficiency
- hepatic dysfunction
- serious cardiac disease
- an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be excluded.
Data sourced from ClinicalTrials.gov (NCT03653429). 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.