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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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.

Belgium1 site

University Hospitals Leuven
Leuven, 3000

Other trials in Belgium

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 groups in NCT03413891
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.

7 Feb 201819 Mar 2020

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
RecruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
Wisdom Tooth Removal, Antibiotic Prophylaxis

All Tooth Extraction trials

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.

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

Results posted to the registry on 1 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tranexamic Acid Group	108	106
Placebo Group	114	112

Primary outcome: Number of Participants of Oral Bleeding

Time frame: 7 days: from randomization till end of follow-up. Count of participants. Unit: Participants

Measure	Tranexamic Acid Group n = 106	Placebo Group n = 112
Value	28	32

Tranexamic Acid Group vs Placebo Group: Risk Ratio (RR): 0.93 (95% CI 0.60 to 1.42), p =0.72, Chi-squared

Population analysed: Full analysis set: all randomized patients except for those who were lost to follow-up or had a protocol deviation.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From inclusion in the study until patients last visit:in total 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tranexamic Acid Group	0 of 108 (0%)	0 of 108 (0%)	0 of 108
Placebo Group	0 of 114 (0%)	0 of 114 (0%)	0 of 114

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

Related trials for Tooth Extraction

RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
RecruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
Wisdom Tooth Removal, Antibiotic Prophylaxis

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.