Using tranexamic acid to reduce bleeding and swelling in rhinoplasty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.