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NCT Number: NCT05774717

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: TXA

Primary outcomes

  1. Intraoperative bleeding as measured by the weight of surgical sponges used

    Time frame: During surgery

    Weight of surgical sponges used (grams)

  2. Intraoperative bleeding as measured by the volume of blood in suction canister

    Time frame: Intraoperative

    Volume of blood in suction canister (Milliliters)

  3. Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)

    Time frame: Up to one week following surgery.

    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)

  4. Postoperative edema

    Time frame: Up to one week following surgery

    Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)

  5. Postoperative ecchymosis

    Time frame: Up to one week following surgery

    Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)

  6. Postoperative bleeding as measured by the number of medical interventions needed to control bleeding

    Time frame: Up to one week following surgery

    Number of interventions required to control bleeding (surgical or procedural interventions)

Study contacts

Contact information is provided by the study sponsor or research team.

Jaclyn Lee, MD

CONTACT

[email protected]

(615) 322-6180

Shiayin F Yang, MD

CONTACT

[email protected]

(615) 322-6180

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Mar 20, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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