RecruitingPhase 1

Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

United States60 participantsStarted 2023-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraoperative bleeding as measured by the weight of surgical sponges used

Timeframe: During surgery

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

Timeframe: Intraoperative

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

Timeframe: Up to one week following surgery.

Postoperative edema

Timeframe: Up to one week following surgery

Postoperative ecchymosis

Timeframe: Up to one week following surgery

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

Timeframe: Up to one week following surgery

Trial details

NCT IDNCT05774717

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-01

Contact for this trial

Shiayin F Yang, MD

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

View on ClinicalTrials.gov More Surgery trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Intraoperative bleeding as measured by the weight of surgical sponges used

Timeframe: During surgery

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

Timeframe: Intraoperative

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

Timeframe: Up to one week following surgery.

Postoperative edema

Timeframe: Up to one week following surgery

Postoperative ecchymosis

Timeframe: Up to one week following surgery

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

Timeframe: Up to one week following surgery