Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Tranexamic Acid

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