NCT05774717 Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
| NCT ID | NCT05774717 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2023-04-01 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Shiayin F Yang, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT05774717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05774717 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05774717 currently recruiting?
Yes, NCT05774717 is actively recruiting participants. Contact the research team at jaclyn.lee.1@vumc.org for enrollment information.
Where is the NCT05774717 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05774717 clinical trial?
NCT05774717 is sponsored by Vanderbilt University Medical Center. The principal investigator is Shiayin F Yang, MD at Vanderbilt University Medical Center. The trial plans to enroll 60 participants.