Tranexamic Acid for Bleeding Prophylaxis During Tooth Extraction

Recruiting in Palo Alto (17 mi)

+18 other locations

Overseen by Todd Bertoch, Dr.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Hyloris Developments

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Todd Bertoch, Dr.

Principal Investigator

JBR Clinical Research (CenExcel)

Eligibility Criteria

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.

Inclusion Criteria

I am generally healthy enough to follow the study's procedures.

I am using blood thinners as prescribed.

Your blood platelet count is between 100,000 and 500,000 per microliter.

Treatment Details

Interventions

• Tranexamic Acid (Anti-fibrinolytic agent)

Trial Overview The study is testing Tranexamic Acid Oral Solution (TXA) to see how it affects bleeding in patients taking anticoagulants (blood thinners) during dental extractions.

Participant Groups

Group I: Treatment (T2) Experimental Treatment 1 Intervention

Standard hemostatic measures + Tranexamic Acid Oral Solution 5%

Group II: Treatment (T1) Placebo Group 1 Intervention

Standard hemostatic measures + Placebo matching with Tranexamic Acid Oral Solution 5%

Who Is Running the Clinical Trial?

Hyloris Developments

Lead Sponsor

Trials

1

Recruited

280+