Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

February 25, 2024 updated by: Shiayin Yang, Vanderbilt University Medical Center
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: During surgery
Weight of surgical sponges used (grams)
During surgery
Intraoperative bleeding as measured by the volume of blood in suction canister
Time Frame: Intraoperative
Volume of blood in suction canister (Milliliters)
Intraoperative
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)
Up to one week following surgery.
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)
Up to one week following surgery
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)
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
Number of interventions required to control bleeding (surgical or procedural interventions)
Up to one week following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Shiayin F Yang, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

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)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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