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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Tooth Extraction

Intervention / Treatment
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* Drug: Tranexamic Acid
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>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<br>* Mouthwash<br>|
| Experimental: Tranexamic Acid Group<br>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<br>* Mouthwash<br>* Other names: Exacyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral bleeding | Any oral bleeding (early or delayed; minor, clinically relevant or major) | 7 days: from randomization till end of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural bleeding score | Bleeding score assigned by operator (VAS 0-10) | Day of extraction | 
| Early bleeding | Any oral bleeding occurring after the extraction up to and including day 1 after the extraction | 1 day | 
| Delayed bleeding | Any oral bleeding occurring between day 2 and day 7 | 6 days | 
| Minor bleeding | Any oral bleeding not requiring unplanned medical contact | 7 days | 
| Clinically-relevant bleeding | Any oral bleeding requiring unplanned medical contact | 7 days | 
| Major bleeding | Any oral bleeding requiring blood transfusion, hospitalization or resulting in death | 7 days | 
| The number of reinterventions | Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon | 7 days | 
| The number of unplanned interruptions of direct oral anticoagulant therapy | The number of unplanned interruptions of direct oral anticoagulant therapy | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulants, Tranexamic Acid