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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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one week following surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one week following surgery
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 moreSide effects data
From 2012 Phase 4 trial • 100 Patients • NCT0074011622%
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
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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
672,132 Total Patients Enrolled
4 Trials studying Surgery
455 Patients Enrolled for Surgery
Shiayin F Yang, MDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have low platelet count (<150,000).I have an active blood clotting disorder.You have color vision problems.I have not had any other facial or sinus surgery at the same time.I have had a heart attack, stroke, seizure, or liver failure.I am over 18 and choosing to have a nose surgery for cosmetic or functional reasons by Drs. Yang or Patel at VUMC.My blood tests show low platelets, high PT, and INR >1.2; I have a seizure disorder.I am currently taking blood thinners.I have an irregular heartbeat.My diabetes is not under control, making it unsafe to use dexamethasone around the time of surgery.I have a history of blood clotting issues.I have had blood clots in my veins or arteries.You are allergic to tranexamic acid (TXA).I have had bleeding in my brain.I have been diagnosed with severe kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Tranexamic Acid
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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