Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

NCT05774717 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 221035
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Postoperative Blood Loss

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.

Drug: Tranexamic acid

Control

NO INTERVENTION

Routine care, no tranexamic acid given.

Interventions

Tranexamic acid DRUG

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.

Also known as: TXA

Tranexamic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 33208696 BACKGROUND

• 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.

  PMID: 30098161 BACKGROUND

• 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.

  PMID: 31204198 BACKGROUND

• 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.

  PMID: 33791652 BACKGROUND

• 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.

  PMID: 35031005 BACKGROUND

• 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.

  PMID: 40042121 DERIVED

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Shiayin F Yang, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Jaclyn S Lee, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

• Alexander J Barna, MPH

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Shiayin F Yang, MD

CONTACT

(615) 322-6180; jaclyn.lee.1@vumc.org

Jaclyn Lee, MD

CONTACT

(615) 322-6180; jaclyn.lee.1@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Provider will order tranexamic acid based based on even versus odd last digit of medical record number (MRN). Patient will be blinded, as will all personnel analyzing postoperative photographs and other data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otolaryngology

Model Details: One group receives tranexamic acid prior to surgery, one group receives nothing (routine care).

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: March 20, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)