RecruitingPhase 1NCT05774717

Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis


Sponsor

Vanderbilt University Medical Center

Enrollment

60 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will be a prospective randomized study to evaluate the effect of tranexamic acid (TXA) use on intraoperative and postoperative outcomes among patients undergoing rhinoplasty by two Facial Plastic surgeons at Vanderbilt. Outcomes will include intra- and post-operative bleeding and postoperative bruising and swelling.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether tranexamic acid (TXA) — a drug commonly used to reduce bleeding during surgery — can reduce bruising, swelling, and bleeding during and after rhinoplasty (nose reshaping surgery). Rhinoplasty, especially when it involves repositioning the nasal bones (osteotomies), can cause significant bruising and swelling around the eyes and face during recovery. TXA works by preventing the breakdown of blood clots, which may reduce these effects. Adults aged 18 and older undergoing primary open rhinoplasty with osteotomies at Vanderbilt University Medical Center are eligible. The study is limited to procedures performed by specific surgeons, and participants cannot be having simultaneous other facial or sinus procedures. Patients are excluded if they have a known allergy to TXA, a history of blood clots, kidney disease, heart rhythm problems, a history of stroke or seizure, uncontrolled diabetes, abnormal clotting labs, active blood-thinning medications, or intracranial bleeding. Participants receive either TXA or a placebo during surgery, with bruising, swelling, and blood loss measured at follow-up visits. This research matters to the millions of patients who undergo rhinoplasty each year — reducing post-operative bruising and swelling not only improves comfort and cosmetic recovery but could also reduce the risk of surgical complications.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTranexamic acid

1 gram IV (intravenous) tranexamic acid administered in the operating room just prior to starting the case (10 minutes), at time that routine preoperative antibiotic is given.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT05774717


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