The Effect of Different Dose Regimens of Tranexamic Acid in Reducing Blood Loss in Rhinoplasty: A Prospective Randomized Controlled Study.
Hakan Avci
https://pubmed.ncbi.nlm.nih.gov/33208696Actively Recruiting
Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID05774717
Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
Led by Vanderbilt University Medical Center · Updated on 2026-05-07
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of tranexamic acid (TXA) on bleeding, swelling, and bruising in patients undergoing rhinoplasty surgery. This prospective randomized study involves patients treated by two facial plastic surgeons at Vanderbilt University Medical Center. The study aims to understand how TXA may influence intraoperative and postoperative outcomes such as bleeding during surgery and swelling and bruising afterward. Participants will be randomly assigned to receive either 1 gram of intravenous TXA in the operating room before surgery or routine care without TXA. The treatment is administered just prior to the surgical incision, alongside the usual preoperative antibiotics. The study anticipates enrolling between 60 and 100 patients, comparing those given TXA versus those who are not, to assess differences in bleeding and postoperative symptoms. During the study, participants will be monitored for bleeding through surgical sponge weight and suction canister volume during the operation. Postoperative assessments include patient ratings of bleeding using a visual scale, as well as evaluations of swelling and bruising up to one week after surgery. Researchers will also track any medical interventions needed to control bleeding, ensuring comprehensive safety monitoring throughout the perioperative period.
CONDITIONS
Brief Title
Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults at least 18 years of age who elect to undergo cosmetic or functional open primary rhinoplasty with osteotomies by Drs. Yang or Patel at Vanderbilt University Medical Center
- No other facial plastic procedures or sinus surgery performed at the same time
- Must not meet any of the exclusion criteria
You will not qualify if you...
- Known allergy to tranexamic acid (TXA)
- Intracranial bleeding
- Known defective color vision
- History of venous or arterial thromboembolism
- Active thromboembolic disease
- Severe renal impairment (chronic kidney disease)
- History of coagulation disorder
- Known thrombocytopenia (platelets less than 150,000)
- Current use of anticoagulant (blood thinner)
- Uncontrolled diabetes mellitus preventing use of dexamethasone perioperatively
- Cardiac arrhythmia
- History of acute myocardial infarction, stroke, seizure, or liver failure
- Laboratory results showing platelets less than 150,000, prothrombin time over 45, INR over 1.2, or seizure disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of surgery
Participants undergo rhinoplasty surgery and receive either 1 gram IV tranexamic acid or placebo in the operating room just before surgical incision.
1 visit (in-person, surgery day)
Post-operative Follow-up
Duration - Up to 1 week following surgery
Participants are monitored for bleeding, swelling, and bruising after surgery.
Approximately 2 to 3 visits (in-person or remote) during the first week after surgery
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
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Research Team
S
Shiayin F Yang, MD
J
Jaclyn Lee, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Preoperative Tranexamic Acid for Treatment of Bleeding, Edema, and Ecchymosis in Patients Undergoing Rhinoplasty: A Systematic Review and Meta-analysis.
Sara Juliana de A de Vasconcellos, Edmundo M do Nascimento-Júnior, Marcel Vinícius de Aguiar Menezes...
https://pubmed.ncbi.nlm.nih.gov/30098161Effect of single-dose intravenous tranexamic acid on postoperative nasal bleed in septoplasty.
S U Zaman, I Zakir, Q Faraz...
https://pubmed.ncbi.nlm.nih.gov/31204198Tranexamic Acid in Aesthetic Facial Plastic Surgery: A Systematic Review of Evidence, Applications, and Outcomes.
Garrett D Locketz, Kirkland N Lozada, Jason D Bloom
https://pubmed.ncbi.nlm.nih.gov/33791652Comparison of the effects of remifentanil and dexmedetomidine on surgeon satisfaction with surgical field visualization and intraoperative bleeding during rhinoplasty.
Reza Jouybar, Maryam Nemati, Naeimehossadat Asmarian
https://pubmed.ncbi.nlm.nih.gov/35031005Intravenous Tranexamic Acid in Rhinoplasty: A Randomized Controlled Trial.
Elizabeth S Longino, Nicole G Desisto, Feyi Adegboye...
https://pubmed.ncbi.nlm.nih.gov/40042121