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

Phase 4

Terminated

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	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).
Tranexamic Acid Group	Tranexamic Acid	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants of Oral Bleeding	7 days: from randomization till end of follow-up	Any oral bleeding (early or delayed; minor, clinically relevant or major)

Secondary Outcome Measures

Name	Time	Method
Clinically-relevant Bleeding	7 days	Any oral bleeding requiring unplanned medical contact
Procedural Bleeding Score	Day of extraction	The Procedural bleeding score assigned by operator (VAS 0-10): Visual analogue score: ranging from 0 (no bleeding) to 10 (unstoppable bleeding)
Major Bleeding	7 days	Any oral bleeding requiring blood transfusion, hospitalization or resulting in death
Number of Unplanned Medical Contacts	7 days	Unplanned medical contact by phone, new consultation or hospitalization with any health care professional (dentist, general practioner, maxillofacial surgeon)
Early Bleeding	2 days	Any oral bleeding occurring after the extraction up to and including day 1 after the extraction
Delayed Bleeding	6 days	Any oral bleeding occurring between day 2 and day 7
Minor Bleeding	7 days	Any oral bleeding not requiring unplanned medical contact
The Number of Reinterventions	7 days	Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon
The Number of Participants With Unplanned Interruptions of Direct Oral Anticoagulant Therapy	7 days	The number of particpants with unplanned interruptions of direct oral anticoagulant therapy