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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

Summary

This trial tests a liquid medicine called Tranexamic Acid to help prevent bleeding in patients on blood thinners who need tooth extractions. The medicine works by helping the blood to clot and reducing bleeding. Tranexamic acid (TXA) has been used around the world to safely control bleeding since the 1960s.

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of clinically relevant postoperative oral bleeding episodes
Secondary study objectives
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for gingival bleeding, particularly in patients with bleeding disorders, include antifibrinolytic agents such as Tranexamic Acid. These agents work by inhibiting fibrinolysis, the process that breaks down blood clots. By preventing the breakdown of fibrin, the protein that forms the meshwork of a blood clot, Tranexamic Acid helps stabilize the clot and reduce bleeding. This mechanism is crucial for patients with gingival bleeding as it helps maintain hemostasis during and after dental procedures, thereby minimizing the risk of excessive bleeding and promoting faster healing.
Dental extraction in congenital hemorrhagic patients.Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions.Management of Single Uncomplicated Dental Extractions and Postoperative Bleeding Evaluation in Patients With Factor V Deficiency: A Local Antihemorrhagic Approach.

Find a Location

Who is running the clinical trial?

Hyloris DevelopmentsLead Sponsor
Todd Bertoch, Dr.Principal InvestigatorJBR Clinical Research (CenExcel)
~65 spots leftby Dec 2024
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