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Antifibrinolytic Agent

Tranexamic Acid for Postoperative Hemorrhage in Rhinoplasty Surgery

Phase 1
Recruiting
Led By Shiayin F Yang, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No other facial plastics procedure nor sinus surgery performed simultaneously
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights

Study Summary

This trial studies how tranexamic acid affects outcomes of rhinoplasty, such as bleeding and swelling.

Who is the study for?
This trial is for adults over 18 ready for primary rhinoplasty without other facial or sinus surgeries. Candidates must not have bleeding disorders, low platelets, be on blood thinners, have uncontrolled diabetes, heart issues like arrhythmia or past heart attacks, strokes, seizures, liver failure; color vision defects; history of clots; allergy to TXA; brain bleeds; severe kidney disease or active clotting conditions.Check my eligibility
What is being tested?
The study tests if tranexamic acid (TXA) can reduce bleeding during and after nose surgery (rhinoplasty), as well as lessen post-surgery bruising and swelling. It's a forward-looking study where patients are randomly chosen to receive TXA and their surgical outcomes are compared.See study design
What are the potential side effects?
Tranexamic acid may cause side effects such as nausea, diarrhea, muscle cramps or spasms. Rarely it could lead to more serious risks like blood clots in the veins or arteries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not had any other facial or sinus surgery at the same time.
Select...
I am over 18 and choosing to have a nose surgery for cosmetic or functional reasons by Drs. Yang or Patel at VUMC.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one week following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one week following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intraoperative bleeding as measured by the volume of blood in suction canister
Intraoperative bleeding as measured by the weight of surgical sponges used
Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)
+3 more

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116
22%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tranexamic AcidExperimental Treatment1 Intervention
Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.
Group II: ControlActive Control1 Intervention
Routine care, no tranexamic acid given.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
2018
Completed Phase 4
~42540

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,172 Total Patients Enrolled
4 Trials studying Surgery
455 Patients Enrolled for Surgery
Shiayin F Yang, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Tranexamic acid (Antifibrinolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05774717 — Phase 1
Surgery Research Study Groups: Tranexamic Acid, Control
Surgery Clinical Trial 2023: Tranexamic acid Highlights & Side Effects. Trial Name: NCT05774717 — Phase 1
Tranexamic acid (Antifibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05774717 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for new participants in this medical experiment?

"Information posted on clinicaltrials.gov states that the trial is not presently searching for participants; the study was initially advertised April 1st 2023 and last updated March 15th 2023. Despite this, there are still 274 other trials actively recruiting patients."

Answered by AI

Is Tranexamic Acid an acceptable risk for human consumption?

"While the efficacy of Tranexamic Acid is still uncertain, data has demonstrated that it poses a minimal risk to patients. Our team at Power therefore assigned this drug a safety rating of 1 out of 3 on our scale."

Answered by AI
~25 spots leftby Feb 2025