Recruiting
Phase 1

Tranexamic Acid

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05774717

Conditions

Surgery

Postoperative Blood Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tranexamic acid

Study Details

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

Study ID

NCT05774717

Start date

Apr 1, 2023

Status verified date

Apr, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Tranexamic Acid

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

no intervention: Control

Routine care, no tranexamic acid given.

Interventions

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.

Primary outcome measure

  • Intraoperative bleeding as measured by the weight of surgical sponges used [ Time Frame: During surgery ]
  • Intraoperative bleeding as measured by the volume of blood in suction canister [ Time Frame: Intraoperative ]
  • Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS) [ Time Frame: Up to one week following surgery. ]
  • Postoperative edema [ Time Frame: Up to one week following surgery ]
  • Postoperative ecchymosis [ Time Frame: Up to one week following surgery ]
  • Postoperative bleeding as measured by the number of medical interventions needed to control bleeding [ Time Frame: Up to one week following surgery ]

Central Contacts and Locations

Central contacts

Shiayin F Yang, MD

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

Jaclyn Lee, MD

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

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Shiayin F Yang, MD

(615) 322-6180elizabeth.d.stephenson.1@vumc.org

Elizabeth S Longino, MD

(615) 322-6180elizabeth.d.stephenson.1@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-07.