Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction (EXTRACT-NOAC)

Universitaire Ziekenhuizen KU Leuven

Status and phase: Terminated; Phase 4

Conditions: Tooth Extraction

Treatments: Other: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03413891

S60131

Details and patient eligibility

About

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.

Full 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

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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222 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo

Tranexamic Acid Group

Experimental group

Description:

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).

Treatment:

Drug: Tranexamic Acid