Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Postoperative Blood Loss
• Intervention / Treatment: Drug: Tranexamic acid

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shiayin F Yang, MD; Phone Number: (615) 322-6180; Email: jaclyn.lee.1@vumc.org
• Study Contact Backup: Name: Jaclyn Lee, MD; Phone Number: (615) 322-6180; Email: jaclyn.lee.1@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Shiayin F Yang, MD; Phone Number: (615) 322-6180; Email: elizabeth.d.stephenson.1@vumc.org
      • Contact: Elizabeth S Longino, MD; Phone Number: (615) 322-6180; Email: elizabeth.d.stephenson.1@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid; Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.	Drug: Tranexamic 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.; Other Names: TXA
No Intervention: Control; Routine care, no tranexamic acid given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative bleeding as measured by the weight of surgical sponges used	Weight of surgical sponges used (grams)	During surgery
Intraoperative bleeding as measured by the volume of blood in suction canister	Volume of blood in suction canister (Milliliters)	Intraoperative
Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)	A single patient-answered question visual analog scale (VAS) used to measure the amount of post-operative bleeding from the nose the participant experienced (1 to 5 scale with 5 being the most)	Up to one week following surgery.
Postoperative edema	Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)	Up to one week following surgery
Postoperative ecchymosis	Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)	Up to one week following surgery
Postoperative bleeding as measured by the number of medical interventions needed to control bleeding	Number of interventions required to control bleeding (surgical or procedural interventions)	Up to one week following surgery

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Shiayin F Yang, MD, Vanderbilt University Medical Center; Study Director: Jaclyn S Lee, MD, Vanderbilt University Medical Center; Study Director: Alexander J Barna, MPH, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Avci H. The Effect of Different Dose Regimens of Tranexamic Acid in Reducing Blood Loss in Rhinoplasty: A Prospective Randomized Controlled Study. J Craniofac Surg. 2021 Jul-Aug 01;32(5):e442-e444. doi: 10.1097/SCS.0000000000007247.
• de Vasconcellos SJA, do Nascimento-Junior EM, de Aguiar Menezes MV, Tavares Mendes ML, de Souza Dantas R, Martins-Filho PRS. Preoperative Tranexamic Acid for Treatment of Bleeding, Edema, and Ecchymosis in Patients Undergoing Rhinoplasty: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Sep 1;144(9):816-823. doi: 10.1001/jamaoto.2018.1381.
• Zaman SU, Zakir I, Faraz Q, Akhtar S, Nawaz A, Adeel M. Effect of single-dose intravenous tranexamic acid on postoperative nasal bleed in septoplasty. Eur Ann Otorhinolaryngol Head Neck Dis. 2019 Nov;136(6):435-438. doi: 10.1016/j.anorl.2018.10.019. Epub 2019 Jun 14.
• Locketz GD, Lozada KN, Bloom JD. Tranexamic Acid in Aesthetic Facial Plastic Surgery: A Systematic Review of Evidence, Applications, and Outcomes. Aesthet Surg J Open Forum. 2020 Jun 14;2(3):ojaa029. doi: 10.1093/asjof/ojaa029. eCollection 2020 Sep.
• Jouybar R, Nemati M, Asmarian N. Comparison of the effects of remifentanil and dexmedetomidine on surgeon satisfaction with surgical field visualization and intraoperative bleeding during rhinoplasty. BMC Anesthesiol. 2022 Jan 14;22(1):24. doi: 10.1186/s12871-021-01546-9.
• Longino ES, Desisto NG, Adegboye F, Rebula E, Chowdhury NI, Patel PN, Stephan SJ, Yang SF. Intravenous Tranexamic Acid in Rhinoplasty: A Randomized Controlled Trial. Facial Plast Surg Aesthet Med. 2026 Jan;28(1):87-94. doi: 10.1089/fpsam.2024.0327. Epub 2026 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Hemorrhage; Pathological Conditions, Signs and Symptoms; Postoperative Hemorrhage; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 221035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan at this time to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes