Clinical trial NCT05774717: Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
Official title: Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Surgery
Postoperative Blood Loss
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives tranexamic acid prior to surgery, one group receives nothing (routine care).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative bleeding as measured by the weight of surgical sponges used
timeFrame: During surgery
measure: Intraoperative bleeding as measured by the volume of blood in suction canister
timeFrame: Intraoperative
measure: Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)
timeFrame: Up to one week following surgery.
measure: Postoperative edema
timeFrame: Up to one week following surgery
measure: Postoperative ecchymosis
timeFrame: Up to one week following surgery
measure: Postoperative bleeding as measured by the number of medical interventions needed to control bleeding
timeFrame: Up to one week following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Shiayin F Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Jaclyn S Lee, MD
role: STUDY_DIRECTOR
affiliation: Vanderbilt University Medical Center
name: Alexander J Barna, MPH
role: STUDY_DIRECTOR
References:
citation: Avci H. The Effect of Different Dose Regimens of Tranexamic Acid in Reducing Blood Loss in Rhinoplasty: A Prospective Randomized Controlled Study. J Craniofac Surg. 2021 Jul-Aug 01;32(5):e442-e444. doi: 10.1097/SCS.0000000000007247.
citation: de Vasconcellos SJA, do Nascimento-Junior EM, de Aguiar Menezes MV, Tavares Mendes ML, de Souza Dantas R, Martins-Filho PRS. Preoperative Tranexamic Acid for Treatment of Bleeding, Edema, and Ecchymosis in Patients Undergoing Rhinoplasty: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Sep 1;144(9):816-823. doi: 10.1001/jamaoto.2018.1381.
citation: Zaman SU, Zakir I, Faraz Q, Akhtar S, Nawaz A, Adeel M. Effect of single-dose intravenous tranexamic acid on postoperative nasal bleed in septoplasty. Eur Ann Otorhinolaryngol Head Neck Dis. 2019 Nov;136(6):435-438. doi: 10.1016/j.anorl.2018.10.019. Epub 2019 Jun 14.
citation: Locketz GD, Lozada KN, Bloom JD. Tranexamic Acid in Aesthetic Facial Plastic Surgery: A Systematic Review of Evidence, Applications, and Outcomes. Aesthet Surg J Open Forum. 2020 Jun 14;2(3):ojaa029. doi: 10.1093/asjof/ojaa029. eCollection 2020 Sep.
citation: Jouybar R, Nemati M, Asmarian N. Comparison of the effects of remifentanil and dexmedetomidine on surgeon satisfaction with surgical field visualization and intraoperative bleeding during rhinoplasty. BMC Anesthesiol. 2022 Jan 14;22(1):24. doi: 10.1186/s12871-021-01546-9.