NCT03413891

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tooth Extraction

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Mouthwash
OTHER	Placebo	Mouthwash

Timeline

• Start date: 2018-02-07
• Primary completion: 2020-03-19
• Completion: 2020-03-19
• First posted: 2018-01-29
• Last updated: 2024-08-01
• Results posted: 2024-08-01

Locations

1 site across 1 country: Belgium