SurgeryPhase 1NCT05774717
Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
A Phase 1 study testing Tranexamic acid in people with Surgery and Postoperative Blood Loss, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Postoperative Blood Loss
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Shiayin F Yang, MD, (615) 322-6180, elizabeth.d.stephenson.1@vumc.org
Elizabeth S Longino, MD, (615) 322-6180, elizabeth.d.stephenson.1@vumc.org
About this study
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.
Read the 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
- Being tested
- Tranexamic acid
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called TXA
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.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision. Receives: Drug: Tranexamic acid |
| Control | No intervention | Routine care, no tranexamic acid given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bleeding as measured by the weight of surgical sponges used
Weight of surgical sponges used (grams)
Measured: During surgery
Intraoperative bleeding as measured by the volume of blood in suction canister
Volume of blood in suction canister (Milliliters)
Measured: 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)
Measured: Up to one week following surgery.
Postoperative edema
Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Measured: Up to one week following surgery
Postoperative ecchymosis
Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Measured: 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)
Measured: Up to one week following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives tranexamic acid prior to surgery, one group receives nothing (routine care).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiayin Yang, Vanderbilt University Medical Center
- Investigators
- Shiayin F Yang, MD, Principal investigator, Vanderbilt University Medical CenterJaclyn S Lee, MD, Study director, Vanderbilt University Medical CenterAlexander J Barna, MPH, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774717
- Sponsor's protocol ID
- 221035
- Status last verified
- Apr 2026
- First submitted
- 12 Oct 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this time to share.
Publications
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.
PubMed 33208696de 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.
PubMed 30098161Zaman 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.
PubMed 31204198Locketz 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.
PubMed 33791652Jouybar 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.
PubMed 35031005Longino ES, Desisto NG, Adegboye F, Rebula E, Chowdhury NI, Patel PN, Stephan SJ, Yang SF. Intravenous Tranexamic Acid in Rhinoplasty: A Randomized Controlled Trial. Facial Plast Surg Aesthet Med. 2026 Jan;28(1):87-94. doi: 10.1089/fpsam.2024.0327. Epub 2026 Apr 2.
PubMed 40042121
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
- ClinicalTrials.gov ID
- NCT05774717
- Acronym / sponsor ID
- 221035
- Conditions
- Surgery, Postoperative Blood Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group receives tranexamic acid prior to surgery, one group receives nothing (routine care).
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic acidPatients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision. |
| Control | No intervention | –Routine care, no tranexamic acid given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Known allergy to TXA (tranexamic acid)
- Intracranial bleeding
- Known defective color vision
- History of venous or arterial thromboembolism
- Active thromboembolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: TXA1 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. | Drug | Tranexamic Acid |
Primary outcome
Intraoperative bleeding as measured by the weight of surgical sponges used
Time frame: During surgery
Weight of surgical sponges used (grams)
Intraoperative bleeding as measured by the volume of blood in suction canister
Time frame: Intraoperative
Volume of blood in suction canister (Milliliters)
Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)
Time frame: 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
Time frame: Up to one week following surgery
Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Postoperative ecchymosis
Time frame: 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
Time frame: Up to one week following surgery
Number of interventions required to control bleeding (surgical or procedural interventions)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 33208696Avci 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.
- Background: PubMed 30098161de 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.
- Background: PubMed 31204198Zaman 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.
- Background: PubMed 33791652Locketz 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.
- Background: PubMed 35031005Jouybar 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.
- Derived from this study: PubMed 40042121Longino ES, Desisto NG, Adegboye F, Rebula E, Chowdhury NI, Patel PN, Stephan SJ, Yang SF. Intravenous Tranexamic Acid in Rhinoplasty: A Randomized Controlled Trial. Facial Plast Surg Aesthet Med. 2026 Jan;28(1):87-94. doi: 10.1089/fpsam.2024.0327. Epub 2026 Apr 2.
- Individual participant dataSharing planned: No. No plan at this time to share.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shiayin F Yang, MD principal investigator
Vanderbilt University Medical Center
Jaclyn S Lee, MD study director
Vanderbilt University Medical Center
Alexander J Barna, MPH study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tranexamic acid in people with Surgery and Postoperative Blood Loss, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiayin F Yang, MD ((615) 322-6180, jaclyn.lee.1@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative bleeding as measured by the weight of surgical sponges used (time frame: During surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774717, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.