Clinical trial NCT03413891: Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
Official title: Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Tooth Extraction
Keywords: Anticoagulants
Tranexamic Acid
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2018-01-29
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants of Oral Bleeding
timeFrame: 7 days: from randomization till end of follow-up
Secondary outcomes:
measure: Procedural Bleeding Score
timeFrame: Day of extraction
measure: Early Bleeding
timeFrame: 2 days
measure: Delayed Bleeding
timeFrame: 6 days
measure: Minor Bleeding
timeFrame: 7 days
measure: Clinically-relevant Bleeding
timeFrame: 7 days
measure: Major Bleeding
timeFrame: 7 days
measure: The Number of Reinterventions
timeFrame: 7 days
measure: The Number of Participants With Unplanned Interruptions of Direct Oral Anticoagulant Therapy
timeFrame: 7 days
measure: Number of Unplanned Medical Contacts
timeFrame: 7 days
Other outcomes:
measure: Safety Outcome: Any Non-oral Bleeding
timeFrame: 7 days
measure: Safety Outcome Number of Participants With Thrombotic Event
timeFrame: 7 days
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: UZ Leuven
name: Peter Verhamme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.