NCT03413891

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 7, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

August 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

January 18, 2018

Results QC Date

February 25, 2021

Last Update Submit

February 20, 2024

Conditions

Tooth Extraction

Keywords

AnticoagulantsTranexamic Acid

Outcome Measures

Primary Outcomes (1)

  • Number of Participants of Oral Bleeding

    Any oral bleeding (early or delayed; minor, clinically relevant or major)

    7 days: from randomization till end of follow-up

Secondary Outcomes (9)

  • Procedural Bleeding Score

    Day of extraction

  • Early Bleeding

    2 days

  • Delayed Bleeding

    6 days

  • Minor Bleeding

    7 days

  • Clinically-relevant Bleeding

    7 days

  • +4 more secondary outcomes

Other Outcomes (2)

  • Safety Outcome: Any Non-oral Bleeding

    7 days

  • Safety Outcome Number of Participants With Thrombotic Event

    7 days

Study Arms (2)

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).

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).

Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG

Mouthwash

Also known as: Exacyl
Tranexamic Acid Group
PlaceboOTHER

Mouthwash

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 33939696RESULT

Related Links

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Mrs. Barbara Debaveye
Organization
University Hospitals Leuven
barbara.debaveye@uzleuven.be
003216 341463

Study Officials

  • Peter Verhamme, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 29, 2018

Study Start

February 7, 2018

Primary Completion

March 19, 2020

Study Completion

March 19, 2020

Last Updated

August 1, 2024

Results First Posted

August 1, 2024

Record last verified: 2024-02

Locations

BE(1)