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

Surgery Postoperative Blood Loss

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

Inclusion Criteria2

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

Exclusion Criteria13

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

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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.