Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Known allergy to TXA (tranexamic acid)
Intracranial bleeding
Known defective color vision
History of venous or arterial thromboembolism
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic acid
Drug1 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Tranexamic AcidExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Intraoperative bleeding as measured by the weight of surgical sponges used
Weight of surgical sponges used (grams)
Time frame
During surgery2
Intraoperative bleeding as measured by the volume of blood in suction canister
Volume of blood in suction canister (Milliliters)
Time frame
Intraoperative3
Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)
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)
Time frame
Up to one week following surgery.4
Postoperative edema
Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Time frame
Up to one week following surgerySponsors and contacts
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Source ClinicalTrials.gov