What side effects are associated with this type of intervention?

Common side effects of antifibrinolytic agents like Tranexamic Acid Oral Solution 5% for treating gingival bleeding include gastrointestinal disturbances (nausea, vomiting, diarrhea), dizziness, headache, and allergic reactions (skin rashes, itching). Rarely, severe side effects such as thromboembolic events may occur, particularly in patients predisposed to clotting disorders.

What prior FDA approvals exist?

Tranexamic acid, an antifibrinolytic agent, has been used to manage gingival bleeding by inhibiting the breakdown of blood clots. It is commonly used in the form of mouthwash or oral solution to control bleeding in patients on anticoagulant therapy undergoing dental procedures. While specific FDA approvals for tranexamic acid in the context of gingival bleeding are not detailed, its use in dental settings is well-documented and supported by clinical studies. Other related treatments include aminocaproic acid, another antifibrinolytic agent, which also works by inhibiting fibrinolysis to control bleeding.

What other types of research exist?

Promising alternatives to Tranexamic Acid Oral Solution 5% for gingival bleeding in 2024 include Concizumab and Marstacimab, which are monoclonal antibodies targeting tissue factor pathway inhibitor (TFPI). These agents have shown significant efficacy in reducing bleeding rates in clinical trials. Additionally, local hemostatic measures such as the insertion of oxidized cellulose, compression, suturing, and the use of electrocautery or splints can be effective in managing gingival bleeding, especially in patients on anticoagulant therapy.

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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

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

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

Thromboembolic events

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group

Tranexamic Group

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 2Eligibility criteria met

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.