Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction

Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction

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.

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

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