Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

Vanderbilt University Medical Center

Status and phase

Enrolling

Phase 1

Conditions

Postoperative Blood Loss

Surgery

Treatments

Drug: Tranexamic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT05774717

221035

Details and patient eligibility

About

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.

Full description

TXA is an antifibrinolytic agent that acts to decrease bleeding by stabilizing the fibrin matrix involved in the clotting cascade. The use of TXA, oral or intravenous, has been extensively used and described in the literature to prevent exsanguination in trauma and in various surgical procedures, as well as for heavy menstrual bleeding. It has been used in the perioperative period during various nasal and sinus surgery, and current research in rhinoplasty suggests that its use may decrease intraoperative bleeding and postoperative eye swelling and bruising.

Currently, IV TXA is used at this institution in some cases by some surgeons in the perioperative period in rhinoplasty surgery, though its used is not standardized and has not been studied. This study will randomize patients undergoing rhinoplasty, with consent, to receive TXA or placebo in the perioperative period. The investigators anticipate collecting 60-100 patients. Outcomes will include intraoperative bleeding, postoperative swelling and bruising (both subjective and based on blinded reviewer analysis of postoperative photographs).

TXA has been used in the perioperative period during various nasal and sinus surgery, and current research in rhinoplasty suggests that its use may decrease intraoperative bleeding and postoperative eye swelling and bruising. In these studies, TXA has been given in intravenous and/or oral form in 1-3 doses in the perioperative period, and there have been no serious adverse effects reported. IV TXA is also FDA approved for use at time of tooth extraction to decrease bleeding, and PO TXA is approved use during the menstrual cycle to decrease heavy menstrual bleeding. There are countless studies in the literature supporting use of both IV and PO TXA in trauma, orthopedic and spine surgery and neurosurgery, and it is widely used in clinical practice in these disciplines. It's use in rhinoplasty is growing, yet has not been studied in larger groups.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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