Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis

NCT ID: NCT05774717

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2026-02-01

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.

Conditions

Surgery; Postoperative Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tranexamic Acid

Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

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.

Control

Routine care, no tranexamic acid given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tranexamic 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.

Intervention Type: DRUG

Other Intervention Names

TXA

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Shiayin Yang

Assistant Professor of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiayin F Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Jaclyn S Lee, MD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Alexander J Barna, MPH

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shiayin F Yang, MD

Role: CONTACT

jaclyn.lee.1@vumc.org

(615) 322-6180

Jaclyn Lee, MD

Role: CONTACT

jaclyn.lee.1@vumc.org

(615) 322-6180

Facility Contacts

Shiayin F Yang, MD

Role: primary

elizabeth.d.stephenson.1@vumc.org

615-322-6180

Elizabeth S Longino, MD

Role: backup

elizabeth.d.stephenson.1@vumc.org

(615) 322-6180

References

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.

Reference Type: BACKGROUND

PMID: 33208696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30098161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31204198 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33791652 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35031005 (View on PubMed)

Other Identifiers

221035

Identifier Type: -

Identifier Source: org_study_id