Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Location contact
Elizabeth S Longino, MD
CONTACT
Shiayin F Yang, MD
CONTACT
NCT Number: NCT05774717
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Elizabeth S Longino, MD
CONTACT
Shiayin F Yang, MD
CONTACT
TXA is an antifibrinolytic agent that acts to decrease bleeding by stabilizing the fibrin matrix involved in the clotting cascade. The use of TXA, oral or intravenous, has been extensively used and described in the literature to prevent exsanguination in trauma and in various surgical procedures, as well as for heavy menstrual bleeding. It has been used in the perioperative period during various nasal and sinus surgery, and current research in rhinoplasty suggests that its use may decrease intraoperative bleeding and postoperative eye swelling and bruising.
Currently, IV TXA is used at this institution in some cases by some surgeons in the perioperative period in rhinoplasty surgery, though its used is not standardized and has not been studied. This study will randomize patients undergoing rhinoplasty, with consent, to receive TXA or placebo in the perioperative period. The investigators anticipate collecting 60-100 patients. Outcomes will include intraoperative bleeding, postoperative swelling and bruising (both subjective and based on blinded reviewer analysis of postoperative photographs).
TXA has been used in the perioperative period during various nasal and sinus surgery, and current research in rhinoplasty suggests that its use may decrease intraoperative bleeding and postoperative eye swelling and bruising. In these studies, TXA has been given in intravenous and/or oral form in 1-3 doses in the perioperative period, and there have been no serious adverse effects reported. IV TXA is also FDA approved for use at time of tooth extraction to decrease bleeding, and PO TXA is approved use during the menstrual cycle to decrease heavy menstrual bleeding. There are countless studies in the literature supporting use of both IV and PO TXA in trauma, orthopedic and spine surgery and neurosurgery, and it is widely used in clinical practice in these disciplines. It's use in rhinoplasty is growing, yet has not been studied in larger groups.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 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.
Other names: TXA
Time frame: During surgery
Weight of surgical sponges used (grams)
Time frame: Intraoperative
Volume of blood in suction canister (Milliliters)
Time frame: Up to one week following surgery.
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
Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Time frame: Up to one week following surgery
Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Time frame: Up to one week following surgery
Number of interventions required to control bleeding (surgical or procedural interventions)
Contact information is provided by the study sponsor or research team.
Jaclyn Lee, MD
CONTACT
Shiayin F Yang, MD
CONTACT
Vanderbilt University Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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