Bleeding From TeethPhase 3NCT06143787
Effect of TXA Oral Sol 5% in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction
A Phase 3 study testing Tranexamic acid in people with Bleeding From Teeth and Bleeding Prophylaxis, run by Hyloris Developments at 19 sites in 5 countries.
Trial summary
The purpose of this study is to assess the effect of Tranexamic Acid Oral Solution 5% in patients treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bleeding From Teeth, Bleeding Prophylaxis
- What is being tested?
- Tranexamic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 7 Nov 2023to 27 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide their signed study informed consent to participate.
- Male or female ≥ 18 years of age at screening.
- Body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2, inclusively and body weight ≥ 50 kg.
- Treated regularly for ≥ 3 months with direct oral anticoagu19lant (e.g., edoxaban, apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (e.g., acenocoumarol, warfarin, etc.).
- 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.
- Subjects taking VKAs or DOACs can be enrolled if these are prescribed and used according to the approved product label.
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- Accepting to not discontinue his/her anticoagulant medication on the day of the extraction.
- 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.
- Considered as reasonably healthy to follow the study procedures as documented by the medical history, physical examination, and vital sign assessments.
- Subjects with a platelet count of 100,000-500,000 (inclusive) platelets per microliter.
- Subject with hemoglobin ≥ 12.0 g/dL (male) or ≥ 11.0 g/dL (female).
- Willing to avoid alcohol consumption for the duration of the study.
- Willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent.
- Negative pregnancy test in females of childbearing potential at Screening and Day 1 visit.
- 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.
Who cannot join
- Any coagulation disorders requiring TXA.
- Wisdom teeth extraction.
- History of severe allergy or allergic reactions or hypersensitivity to the study drug or any component of its formulations or related drugs or heparin
- Subjects with type IV periodontitis (as per American Dental Association Classification) (see Appendix 1).
- History of subarachnoid hemorrhage.
- Active intravascular clotting (defined as a history of thrombosis within the past 3 months).
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- Blood in the urine (macroscopic hematuria) at Screening.
- Renal function test result of estimated glomerular filtration rate ≤ 15 mL/min/1.73 m² at Screening.
- 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.
- Any ongoing or planned oncological treatment for the duration of subject's participation in the study.
- Any immunocompromising condition.
- Use of any recreational drugs or history of drug addiction.
- Positive alcohol breath test at Screening and Day 1.
- Participating in any other clinical study or has received treatment with any investigational drug or device within 3 months prior to screening.
- 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]).
- Severe uncontrolled arterial hypertension, e.g., > 200 mmHg systolic or > 110 mmHg diastolic blood pressure at two consecutive readings.
- Subjects who are found positive to human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) serological tests.
- 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.
- Women with intended pregnancy or breast-feeding.
- Planned soft (other than extraction site) or hard oral tissue biopsy on the day of the surgery.
- Subjects who are evaluated to have a negative risk-benefit ratio to participate in this study (e.g., high risk of severe bleeding).
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Spain5 sites, 5 recruiting
- Not yet recruiting
Medicine and Healthcare Science Faculty of Barcelona University (Campus Bellvitge
Barcelona, 08907
Rui Figueiredo, MD
Rui Figueiredo, MD
- Recruiting
Puerta del Mar University Hospital
Cadiz, 11009
Álvaro Povedano, MD
Álvaro Povedano, MD
- Not yet recruiting
Jerez Center Health Center
Jerez de la Frontera, 11403
Javier Codeso, MD
Javier Codeso, MD
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
José Luis Carretero, MD
José Luis Carretero, MD
- Recruiting
Institute of Biotechnology of Seville (IBIS)
Seville, 41009
Daniel Lagares, MD
Daniel Lagares, MD
United States4 sites, 3 recruiting
- Recruiting
Loma Linda University School of Dentistry
Loma Linda, California, 92350
Montry Suprono, MD
Montry Suprono, MD
- Withdrawn
JBR Clinical Research (CenExel)
Millcreek, Utah, 84107
- Recruiting
Roseman University of Health Sciences, College of Dental Medicine
South Jordan, Utah, 84107
Man Hung, MD
Man Hung, MD
- Not yet recruiting
Stamford Therapeutics Consortium
Stamford, Connecticut, 06901
David Radin, dradinmd@gmail.com
Croatia4 sites, 4 recruiting
- Recruiting
Clinical Hospital Center Rijeka, Dental clinic
Rijeka, 51000
Vlatka Debeljak, Assoc. prof.
Vlatka Debeljak, Assoc. prof.
- Not yet recruiting
University Hospital of Split Department of Oral surgery
Split, 21000
Ivan Galić, Prof.
Ivan Galić, Prof.
- Recruiting
Dental Clinic Zagreb
Zagreb, 10000
Petra Fuchs, MD
Petra Fuchs, MD
- Not yet recruiting
University hospital Dubrava Department of oral surgery
Zagreb, 10000
Berislav Perić, Prof.
Berislav Perić, Prof.
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis Egyetem, Fogorvostudományi Kar, Arc-Állcsont-Szájsebészeti És Fogászati Klinika
Budapest, 1085
Németh Zsolt, MD
Németh Zsolt, MD
- Not yet recruiting
SZTE SZAKK Arc-, Állcsont- és Szájsebészeti Klinika
Szeged, 6722
József Piffkó, Prof.Dr
József Piffkó, Prof.Dr
- Not yet recruiting
Arc-, Állcsont-, Szájsebészeti Osztály
Veszprém, 8200
Restár László, MD
Restár László, MD
Romania3 sites, 3 recruiting
- Recruiting
"Dr. Carol Davila" Central Military Emergency University Hospital Bucharest
Bucharest, 010825
Ionescu Matei, MD
Ionescu Matei, MD
- Recruiting
Trident Clinic
Bucharest, 050533
Lucian Chirila, MD
Lucian Chirila, MD
- Recruiting
SCJU Craiova
Craiova, 200642
Adi Camen, MD
Adi Camen, MD
About this study
Official title: 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.
The purpose of this study is to assess the effect of Tranexamic Acid Oral Solution 5% in patients treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction.
Read the detailed description
The purpose of this study is 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.
A total of approximately 280 subjects will be randomized in two equal treatment groups (approximately 140 subjects per group) to receive Tranexamic Acid Oral Solution 5% or placebo solution for 7 days. Following screening, eligible subjects can be randomized within 14 days when all eligibility criteria are confirmed. Randomized subjects will undergo tooth extraction(s) and treatment period. The treatment period ends at Visit 5 followed by the follow-up period. The maximal study duration is about 4 weeks.
- Conditions
- Bleeding From Teeth, Bleeding Prophylaxis
- Being tested
- Tranexamic acid
- Keywords
- bleeding teeth, Tranexamic Acid, Oral Solution, Tranexamic Acid Oral Solution 5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Tranexamic Acid Oral Solution 5%
7 days Oral rinsing following tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Treatment (T1) | Placebo comparator | Standard hemostatic measures + Placebo matching with Tranexamic Acid Oral Solution 5% Receives: Drug: Tranexamic acid |
| Treatment (T2) | Experimental | Standard hemostatic measures + Tranexamic Acid Oral Solution 5% Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinically relevant postoperative oral bleeding episodes
Number of clinically relevant postoperative oral bleeding episodes (including clinically relevant orofacial hematomas)
Measured: 7 days
Secondary outcomes (5)
Number of postoperative oral bleeding episodes
Number of postoperative oral bleeding episodes (including clinically relevant and not clinically relevant bleedings and orofacial hematomas)
Measured: 7 days
Number of delayed postoperative oral bleeding episodes
Number of delayed postoperative oral bleeding episodes, both clinically relevant and not clinically relevant, in all subjects.
Measured: 7 days
Number of early postoperative oral bleeding episodes
Number of early (less than 24 h post-tooth extraction) postoperative oral bleeding episodes, both clinically relevant and not clinically relevant, in all subjects
Measured: 7 days
Perioperative and immediate post-operative duration
Perioperative and immediate post-operative (procedural bleeding) duration (min, all types of oral bleeding).
Measured: 7 days
Medication Acceptability Questionnaire (MAQ) completed
Medication Acceptability Questionnaire (MAQ) for Tranexamic Acid Oral Solution 5% use completed in all subjects
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start7 Nov 2023
- Primary completion27 Dec 2024 (estimated)
- Study completion27 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding From TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, multi-center, placebo-controlled, parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyloris Developments
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Bertoch, Dr., Principal investigator, JBR Clinical Research (CenExcel)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143787
- Sponsor's protocol ID
- HYL-P004-003
- Other IDs
- 2023-503719-13-00, 2023
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06143787
- Acronym / sponsor ID
- HYL-P004-003
- Conditions
- Bleeding From Teeth, Bleeding Prophylaxis
- Keywords
- bleeding teeth, Tranexamic Acid, Oral Solution, Tranexamic Acid Oral Solution 5%
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hyloris DevelopmentsIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 27 Dec 2024 (estimated)
- Study completion
- 27 Dec 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of Tranexamic Acid Oral Solution 5% in patients treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction.
Detailed description
The purpose of this study is 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.
A total of approximately 280 subjects will be randomized in two equal treatment groups (approximately 140 subjects per group) to receive Tranexamic Acid Oral Solution 5% or placebo solution for 7 days. Following screening, eligible subjects can be randomized within 14 days when all eligibility criteria are confirmed. Randomized subjects will undergo tooth extraction(s) and treatment period. The treatment period ends at Visit 5 followed by the follow-up period. The maximal study duration is about 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, multi-center, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| Treatment (T1) | Placebo comparator | Drug: Tranexamic acidStandard hemostatic measures + Placebo matching with Tranexamic Acid Oral Solution 5% |
| Treatment (T2) | Experimental | Drug: Tranexamic acidStandard hemostatic measures + Tranexamic Acid Oral Solution 5% |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provide their signed study informed consent to participate.
- Male or female ≥ 18 years of age at screening.
- Body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2, inclusively and body weight ≥ 50 kg.
- Treated regularly for ≥ 3 months with direct oral anticoagu19lant (e.g., edoxaban, apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (e.g., acenocoumarol, warfarin, etc.).
- 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.
Key exclusion criteria (21 listed)
- Any coagulation disorders requiring TXA.
- Wisdom teeth extraction.
- History of severe allergy or allergic reactions or hypersensitivity to the study drug or any component of its formulations or related drugs or heparin
- Subjects with type IV periodontitis (as per American Dental Association Classification) (see Appendix 1).
- History of subarachnoid hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: Tranexamic Acid Oral Solution 5%7 days Oral rinsing following tooth extraction | Drug | Treatment (T1), Treatment (T2) |
Primary outcome
Number of clinically relevant postoperative oral bleeding episodes
Time frame: 7 days
Number of clinically relevant postoperative oral bleeding episodes (including clinically relevant orofacial hematomas)
5 secondary outcomes
Number of postoperative oral bleeding episodes
Time frame: 7 days
Number of delayed postoperative oral bleeding episodes
Time frame: 7 days
Number of early postoperative oral bleeding episodes
Time frame: 7 days
Perioperative and immediate post-operative duration
Time frame: 7 days
Medication Acceptability Questionnaire (MAQ) completed
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Bertoch, Dr. principal investigator
JBR Clinical Research (CenExcel)
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid in people with Bleeding From Teeth and Bleeding Prophylaxis, run by Hyloris Developments at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain, United States, Croatia, Hungary, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Lyssens (+3243460207, clinical@hyloris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinically relevant postoperative oral bleeding episodes (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.