Home › Trials › NCT06143787

Using Tranexamic Acid Oral Solution to Prevent Bleeding During Tooth Extractions

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Study to Compare the Efficacy, Acceptability, and Safety of Tranexamic Acid Oral Solution 5% With Placebo in the Prevention of Clinically Relevant Bleeding Events in Subjects Treated With Direct Oral Anticoagulants or Vitamin K Antagonists and Undergoing a Single or Multiple Tooth Extraction.

Phase 3 Interventional Hyloris Developments · NCT06143787

This study is testing if a mouth rinse called Tranexamic Acid can help prevent bleeding during tooth extractions for people taking blood thinners.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment280 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorHyloris Developments Industry-sponsored
Locations19 sites (Loma Linda, California and 18 other locations)
Trial IDNCT06143787 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Tranexamic Acid Oral Solution 5% in preventing bleeding in patients who are on direct oral anticoagulants or vitamin K antagonists and are undergoing tooth extractions. Approximately 280 participants will be randomly assigned to receive either the Tranexamic Acid solution or a placebo for a week. The study aims to compare the efficacy, acceptability, and safety of the treatment in reducing clinically relevant bleeding events during and after the dental procedure. Participants will be monitored throughout the treatment and follow-up period, which lasts about four weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been on anticoagulant therapy for at least three months and are scheduled for tooth extractions.

Not a fit: Patients not on anticoagulant therapy or those with contraindications to Tranexamic Acid will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce bleeding complications for patients on anticoagulants undergoing dental procedures.

How similar studies have performed: Previous studies have shown promising results with Tranexamic Acid in reducing bleeding in surgical settings, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Provide their signed study informed consent to participate.
2. Male or female ≥ 18 years of age at screening.
3. Body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2, inclusively and body weight ≥ 50 kg.
4. Treated regularly for ≥ 3 months with direct oral anticoagu19lant (e.g., edoxaban, apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (e.g., acenocoumarol, warfarin, etc.).
5. Subjects on VKAs can be enrolled if the subject's International Normalized Ratio (INR) at screening, but not more than 5 days before the dental extraction procedure is within the range of 2.0-3.5.
6. Subjects taking VKAs or DOACs can be enrolled if these are prescribed and used according to the approved product label.
7. Accepting to not discontinue his/her anticoagulant medication on the day of the extraction.
8. Scheduled to undergo a single or multiple (≤ 5 teeth, single-rooted, double-rooted, or multi-rooted, maximum 3 multi-rooted teeth and 2 different extraction sites) tooth extraction. Subjects with a single extraction site may have up to a maximum of 5 adjacent teeth extracted at the site, and subjects with two extraction sites may have up to a maximum of 3 adjacent extracted teeth at one site and 2 adjacent extracted teeth at the other site.
9. Considered as reasonably healthy to follow the study procedures as documented by the medical history, physical examination, and vital sign assessments.
10. Subjects with a platelet count of 100,000-500,000 (inclusive) platelets per microliter.
11. Subject with hemoglobin ≥ 12.0 g/dL (male) or ≥ 11.0 g/dL (female).
12. Willing to avoid alcohol consumption for the duration of the study.
13. Willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent.
14. Negative pregnancy test in females of childbearing potential at Screening and Day 1 visit.
15. Women must be post-menopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or willing to use highly effective method of birth control which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (refer to Table 4 in protocol Section 8.2.11 for further information on acceptable and unacceptable birth control methods). The Investigator is responsible for determining whether the subject has adequate birth control for study participation.

Exclusion Criteria:

1. Any coagulation disorders requiring TXA.
2. Wisdom teeth extraction.
3. History of severe allergy or allergic reactions or hypersensitivity to the study drug or any component of its formulations or related drugs or heparin
4. Subjects with type IV periodontitis (as per American Dental Association Classification) (see Appendix 1).
5. History of subarachnoid hemorrhage.
6. Active intravascular clotting (defined as a history of thrombosis within the past 3 months).
7. Blood in the urine (macroscopic hematuria) at Screening.
8. Renal function test result of estimated glomerular filtration rate ≤ 15 mL/min/1.73 m² at Screening.
9. Any ongoing or planned dual anti-platelet treatment for the duration of subject's participation in the study (any 2 of the following: aspirin, dipyridamole, or any thienopyridine, i.e., clopidogrel, prasugrel, ticlopidine, ticagrelor). However, subjects receiving a very low dose aspirin (≤ 160 mg) may be enrolled.
10. Any ongoing or planned oncological treatment for the duration of subject's participation in the study.
11. Any immunocompromising condition.
12. Use of any recreational drugs or history of drug addiction.
13. Positive alcohol breath test at Screening and Day 1.
14. Participating in any other clinical study or has received treatment with any investigational drug or device within 3 months prior to screening.
15. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk for treatment complications (including but not limited to diseases such as uncontrolled diabetes, any haemato-oncological condition \[e.g., leukemia\], any congenital hematological condition \[e.g., hemophilia\]).
16. Severe uncontrolled arterial hypertension, e.g., \> 200 mmHg systolic or \> 110 mmHg diastolic blood pressure at two consecutive readings.
17. Subjects who are found positive to human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) serological tests.
18. Use of hormonal methods of birth control that increase the risk of thrombosis (e.g., estrogen-containing contraceptives). Refer to Table 4 in protocol Section 8.2.11 for further information on acceptable and unacceptable birth control methods.
19. Women with intended pregnancy or breast-feeding.
20. Planned soft (other than extraction site) or hard oral tissue biopsy on the day of the surgery.
21. Subjects who are evaluated to have a negative risk-benefit ratio to participate in this study (e.g., high risk of severe bleeding).

Where this trial is running

Loma Linda, California and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bleeding From TeethBleeding Prophylaxisbleeding teethTranexamic AcidOral SolutionTranexamic Acid Oral Solution 5%
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.