Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

Conditions
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Surgery, Postoperative Blood Loss

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion 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 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 <150,000, PT (prothrombin time) >45, INR (international normalized ratio) >1.2, seizure disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group receives tranexamic acid prior to surgery, one group receives nothing (routine care).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision. | Drug: Tranexamic acid<br>* 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.<br>* Other names: TXA;|
| No Intervention: Control<br>Routine care, no tranexamic acid given. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative bleeding as measured by the weight of surgical sponges used | Weight of surgical sponges used (grams) | During surgery | 
| Intraoperative bleeding as measured by the volume of blood in suction canister | Volume of blood in suction canister (Milliliters) | 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) | Up to one week following surgery. | 
| Postoperative edema | Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most) | Up to one week following surgery | 
| Postoperative ecchymosis | Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most) | 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) | Up to one week following surgery |