A Phase 1 interventional study of Tranexamic acid in Surgery and Postoperative Blood Loss, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Prevention
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.
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.
144 studies on the registry are indexed under Postoperative Hemorrhage; 28 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 103 interventional studies indexed under Postoperative Hemorrhage.
Browse Postoperative Hemorrhage studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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Exclusion Criteria:
Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.
Drug: Tranexamic acid
Routine care, no tranexamic acid given.
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.
Also known as: TXA
Intraoperative bleeding as measured by the weight of surgical sponges used
Weight of surgical sponges used (grams)
Time frame: During surgery
Intraoperative bleeding as measured by the volume of blood in suction canister
Volume of blood in suction canister (Milliliters)
Time frame: Intraoperative
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.
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 surgery
Postoperative ecchymosis
Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Time frame: Up to one week following surgery
Postoperative bleeding as measured by the number of medical interventions needed to control bleeding
Number of interventions required to control bleeding (surgical or procedural interventions)
Time frame: Up to one week following surgery
Plan to share: No — No plan at this time to share.
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Vanderbilt University Medical Center