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Official title Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
ClinicalTrials.gov ID: NCT05774717
What this study is testing
What is Tranexamic acid?
Tranexamic acid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for surgery.
Also referred to as TXA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Adults at least 18 years of age who elect to undergo cosmetic or functional open primary rhinoplasty with osteotomies (repositioning the nasal bones)...
- No other facial plastics procedure nor sinus surgery performed simultaneously
- Lack all the below
You likely can't join if
- Exclusion Criteria:
- Known allergy to TXA (tranexamic acid)
- Intracranial bleeding
- Known defective color vision
- History of venous or arterial thromboembolism
- Active thromboembolic disease
See the full eligibility 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:
- 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 \ 45, INR (international normalized ratio) \>1.2, seizure disorder
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.