Using tranexamic acid to reduce bleeding and swelling in rhinoplasty
Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
This study is testing if giving tranexamic acid during nose surgery can help reduce bleeding and swelling for patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05774717 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of tranexamic acid (TXA) on intraoperative and postoperative outcomes in patients undergoing rhinoplasty. It is a prospective randomized trial where participants will receive either TXA or a placebo during the perioperative period. The study aims to assess outcomes such as bleeding, bruising, and swelling through both subjective reports and blinded photographic analysis. The research is being conducted by two facial plastic surgeons at Vanderbilt University Medical Center, with an anticipated enrollment of 60-100 patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing cosmetic or functional open primary rhinoplasty with osteotomies.
Not a fit: Patients with a history of thromboembolic disease, severe renal impairment, or those currently using anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced bleeding and swelling for patients undergoing rhinoplasty, improving recovery outcomes.
How similar studies have performed: Previous studies have shown that TXA can effectively reduce bleeding and swelling in various surgical procedures, suggesting potential success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults at least 18 years of age who elect to undergo cosmetic or functional open primary rhinoplasty with osteotomies (repositioning the nasal bones) by Drs. Yang or Patel at VUMC. * No other facial plastics procedure nor sinus surgery performed simultaneously * Lack all the below Exclusion Criteria Exclusion Criteria: * Known allergy to TXA (tranexamic acid) * Intracranial bleeding * Known defective color vision * History of venous or arterial thromboembolism * Active thromboembolic disease * Severe renal impairment (diagnosis of chronic kidney disease) * History of coagulation disorder * Known thrombocytopenia (platelets \<150,000) * Current use of anticoagulant (blood thinner) * Uncontrolled DM (diabetes mellitus) preventing use of dexamethasone in the perioperative period * Cardiac arrhythmia * History of AMI (acute myocardial infarction), stroke, seizure, liver failure * Laboratory results showing platelets \<150,000, PT (prothrombin time) \>45, INR (international normalized ratio) \>1.2, seizure disorder
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Shiayin F Yang, MD — Vanderbilt University Medical Center
- Study coordinator: Shiayin F Yang, MD
- Email: jaclyn.lee.1@vumc.org
- Phone: (615) 322-6180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.