Postoperative Blood Loss, Surgery
Conditions
Brief summary
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
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.
Interventions
DRUGTranexamic acid
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Provider will order tranexamic acid based based on even versus odd last digit of medical record number (MRN). Patient will be blinded, as will all personnel analyzing postoperative photographs and other data.
Intervention model description
One group receives tranexamic acid prior to surgery, one group receives nothing (routine care).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative bleeding as measured by the weight of surgical sponges used | During surgery | Weight of surgical sponges used (grams) |
| Intraoperative bleeding as measured by the volume of blood in suction canister | Intraoperative | Volume of blood in suction canister (Milliliters) |
| Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS) | 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) |
| Postoperative edema | Up to one week following surgery | Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most) |
| Postoperative ecchymosis | Up to one week following surgery | Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most) |
| Postoperative bleeding as measured by the number of medical interventions needed to control bleeding | Up to one week following surgery | Number of interventions required to control bleeding (surgical or procedural interventions) |
Countries
United States
Contacts
CONTACTShiayin F Yang, MD
CONTACTJaclyn Lee, MD
PRINCIPAL_INVESTIGATORShiayin F Yang, MD
Vanderbilt University Medical Center
STUDY_DIRECTORJaclyn S Lee, MD
Vanderbilt University Medical Center
STUDY_DIRECTORAlexander J Barna, MPH
Vanderbilt University Medical Center
Outcome results
None listed