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Tranexamic Acid for Bleeding Prophylaxis During Tooth Extraction

Phase 3
Recruiting
Led By Todd Bertoch, Dr.
Research Sponsored by Hyloris Developments
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo a single or multiple tooth extraction
Treated regularly for ≥ 3 months with direct oral anticoagulant (e.g., edoxaban, apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (e.g., acenocoumarol, warfarin, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial aims to see if a drug can help people on blood thinners safely have teeth pulled.

Who is the study for?
Adults over 18, with a BMI of 18.5-35 and weight above 50 kg, on blood thinners like DOACs or VKAs for at least 3 months, can join this trial if they're having teeth pulled out. They need normal platelet counts and hemoglobin levels, and women must not be pregnant and use effective birth control.Check my eligibility
What is being tested?
The study is testing Tranexamic Acid Oral Solution (TXA) to see how it affects bleeding in patients taking anticoagulants (blood thinners) during dental extractions.See study design
What are the potential side effects?
Tranexamic acid may cause side effects such as nausea, diarrhea, vomiting; less commonly dizziness or headaches might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a tooth extraction soon.
Select...
I have been on blood thinners like warfarin or apixaban for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of clinically relevant postoperative oral bleeding episodes
Secondary outcome measures
Medication Acceptability Questionnaire (MAQ) completed
Number of delayed postoperative oral bleeding episodes
Number of early postoperative oral bleeding episodes
+2 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
Placebo Group
Group I: Treatment (T2)Experimental Treatment1 Intervention
Standard hemostatic measures + Tranexamic Acid Oral Solution 5%
Group II: Treatment (T1)Placebo Group1 Intervention
Standard hemostatic measures + Placebo matching with Tranexamic Acid Oral Solution 5%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
2018
Completed Phase 4
~42540

Find a Location

Who is running the clinical trial?

Hyloris DevelopmentsLead Sponsor
Todd Bertoch, Dr.Principal InvestigatorJBR Clinical Research (CenExcel)

Frequently Asked Questions

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

Has Treatment (T2) received regulatory clearance from the FDA?

"According to our internal metrics, Treatment (T2) is rated at 3 due to a Phase 3 trial that provides evidence for both its efficacy and safety."

Answered by AI

Are researchers still recruiting participants for this experiment?

"As per the records on clinicaltrials.gov, this trial is actively looking for participants and was last updated on November 21st 2023. The study had initially been posted to the website on November 7th of that year."

Answered by AI

Would I qualify to partake in this experiment?

"To be part of the trial, potential participants must present with gingival bleeding and fall within a certain age bracket (18-99). The recruitment goal for this study is 280 patients."

Answered by AI

Are octogenarians being admitted to this experiment?

"The qualifications for this medical trial indicate that participants must be aged 18 to 99, inclusive."

Answered by AI

What is the quota for enrolment in this investigation?

"That is correct. According to records from clinicaltrials.gov, this research study was initially posted on November 7th 2023 and modified most recently on November 21st of the same year. The investigation requires 280 individuals across 19 different sites for enrollment."

Answered by AI

What is the geographic scope of this experiment?

"Roseman University of Health Sciences, College of Dental Medicine in South Jordan, University hospital Dubrava Department of oral surgery in Zagreb and Semmelweis Egyetem, Fogorvostudományi Kar, Arc-Állcsont-Szájsebészeti És Fogászati Klinika in Budapest are amongst the 19 medical centres currently enrolling patients for this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of TXA Oral Sol 5% in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction
2023. "Effect of TXA Oral Sol 5% in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06143787.
~40 spots leftby Jun 2024
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