Tooth ExtractionPhase 4EXTRACT-NOACNCT03413891
Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
A Phase 4 study testing Tranexamic Acid in people with Tooth Extraction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In patients treated with direct oral anticoagulants, bleeding events during or after tooth extraction can lead to unscheduled interruption of the antithrombotic treatment and a potential increased risk of thrombo-embolic events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction
- 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
- 222 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Feb 2018to 19 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for dental extraction and treated with edoxaban, apixaban, rivaroxaban or dabigatran
- Not having taken the direct oral anticoagulant on the day of the extraction
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.
- Pregnancy or lactation
- Known allergic reaction to tranexamic acid
Trial locations and contacts
1 site in 1 country.
About this study
In patients treated with direct oral anticoagulants, bleeding events during or after tooth extraction can lead to unscheduled interruption of the antithrombotic treatment and a potential increased risk of thrombo-embolic events. Therefore, an optimal strategy to minimize bleeding events after tooth extractions is required. In this study, the investigators want to assess whether adding tranexamic acid mouthwash reduces the number of bleeding events in patients treated with direct oral anticoagulants and undergoing a tooth extraction.
Read the detailed description
Interventional phase IV, randomized, double-blind, placebo-controlled trial:
- Feasibility: a 3-day regimen of tranexamic acid mouthwash in patients treated with direct oral anticoagulants
- Efficacy: reduction of bleeding events after tooth extraction compared to placebo
- Safety: any non-oral bleeding or thrombo-embolic events
- Conditions
- Tooth Extraction
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Anticoagulants, Tranexamic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Exacyl
Mouthwash
PlaceboOther
Mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction). Receives: Other: Placebo |
| Tranexamic Acid Group | Experimental | 10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction). Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants of Oral Bleeding
Any oral bleeding (early or delayed; minor, clinically relevant or major)
Measured: 7 days: from randomization till end of follow-up
Secondary outcomes (9)
Procedural Bleeding Score
The Procedural bleeding score assigned by operator (VAS 0-10): Visual analogue score: ranging from 0 (no bleeding) to 10 (unstoppable bleeding)
Measured: Day of extraction
Early Bleeding
Any oral bleeding occurring after the extraction up to and including day 1 after the extraction
Measured: 2 days
Delayed Bleeding
Any oral bleeding occurring between day 2 and day 7
Measured: 6 days
Minor Bleeding
Any oral bleeding not requiring unplanned medical contact
Measured: 7 days
Clinically-relevant Bleeding
Any oral bleeding requiring unplanned medical contact
Measured: 7 days
Major Bleeding
Any oral bleeding requiring blood transfusion, hospitalization or resulting in death
Measured: 7 days
The Number of Reinterventions
Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon
Measured: 7 days
The Number of Participants With Unplanned Interruptions of Direct Oral Anticoagulant Therapy
The number of particpants with unplanned interruptions of direct oral anticoagulant therapy
Measured: 7 days
Number of Unplanned Medical Contacts
Unplanned medical contact by phone, new consultation or hospitalization with any health care professional (dentist, general practioner, maxillofacial surgeon)
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 posted29 Jan 2018
- Study start7 Feb 2018
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Why it stopped: Advice from DSMB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Principal investigator, Peter Verhamme, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Peter Verhamme, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413891
- Sponsor's protocol ID
- S60131
- Acronym
- EXTRACT-NOAC
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2018
- Last updated
- 1 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ockerman A, Miclotte I, Vanhaverbeke M, Vanassche T, Belmans A, Vanhove J, Meyns J, Nadjmi N, Van Hemelen G, Winderickx P, Jacobs R, Politis C, Verhamme P. Tranexamic acid and bleeding in patients treated with non-vitamin K oral anticoagulants undergoing dental extraction: The EXTRACT-NOAC randomized clinical trial. PLoS Med. 2021 May 3;18(5):e1003601. doi: 10.1371/journal.pmed.1003601. eCollection 2021 May.
PubMed 33939696
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
- Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
- ClinicalTrials.gov ID
- NCT03413891
- Acronym / sponsor ID
- EXTRACT-NOAC / S60131
- Conditions
- Tooth Extraction
- Keywords
- Anticoagulants, Tranexamic Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Advice from DSMB
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Posted 1 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients treated with direct oral anticoagulants, bleeding events during or after tooth extraction can lead to unscheduled interruption of the antithrombotic treatment and a potential increased risk of thrombo-embolic events. Therefore, an optimal strategy to minimize bleeding events after tooth extractions is required. In this study, the investigators want to assess whether adding tranexamic acid mouthwash reduces the number of bleeding events in patients treated with direct oral anticoagulants and undergoing a tooth extraction.
Detailed description
Interventional phase IV, randomized, double-blind, placebo-controlled trial:
- Feasibility: a 3-day regimen of tranexamic acid mouthwash in patients treated with direct oral anticoagulants
- Efficacy: reduction of bleeding events after tooth extraction compared to placebo
- Safety: any non-oral bleeding or thrombo-embolic events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Placebo10mL water as mouthwash with white cherry flavor in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction). |
| Tranexamic Acid Group | Experimental | Drug: Tranexamic Acid10mL tranexamic acid mouthwash 10% in oral syringes. Once before tooth extraction and 3 times daily during 3 days post-extraction (starting day after extraction). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for dental extraction and treated with edoxaban, apixaban, rivaroxaban or dabigatran
- Not having taken the direct oral anticoagulant on the day of the extraction
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria (3 listed)
- Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.
- Pregnancy or lactation
- Known allergic reaction to tranexamic acid
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: ExacylMouthwash | Drug | Tranexamic Acid Group |
| PlaceboMouthwash | Other | Control Group |
Primary outcome
Number of Participants of Oral Bleeding
Time frame: 7 days: from randomization till end of follow-up
Any oral bleeding (early or delayed; minor, clinically relevant or major)
9 secondary outcomes
Procedural Bleeding Score
Time frame: Day of extraction
Early Bleeding
Time frame: 2 days
Delayed Bleeding
Time frame: 6 days
Minor Bleeding
Time frame: 7 days
Clinically-relevant Bleeding
Time frame: 7 days
Major Bleeding
Time frame: 7 days
The Number of Reinterventions
Time frame: 7 days
The Number of Participants With Unplanned Interruptions of Direct Oral Anticoagulant Therapy
Time frame: 7 days
Number of Unplanned Medical Contacts
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33939696Ockerman A, Miclotte I, Vanhaverbeke M, Vanassche T, Belmans A, Vanhove J, Meyns J, Nadjmi N, Van Hemelen G, Winderickx P, Jacobs R, Politis C, Verhamme P. Tranexamic acid and bleeding in patients treated with non-vitamin K oral anticoagulants undergoing dental extraction: The EXTRACT-NOAC randomized clinical trial. PLoS Med. 2021 May 3;18(5):e1003601. doi: 10.1371/journal.pmed.1003601. eCollection 2021 May.
- Pmed publicationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Peter Verhamme, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid in people with Tooth Extraction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 3 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: stopped early, 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 1 site in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants of Oral Bleeding (time frame: 7 days: from randomization till end of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03413891, which also lists 1 linked publication.
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.