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

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.

Timeline

Start

2018-02-07

Primary completion

2020-03-19

Completion

2020-03-19

Outcome

Missed primary endpoint

Stopped: “Advice from DSMB”

registry analysis (superiority test); Tranexamic Acid Group vs Placebo Group; p =0.72; Risk Ratio (RR) 0.93 (95% CI 0.60 to 1.42); NCT03413891 ↗

Publications

• Results Ockerman A, Miclotte I, Vanhaverbeke M, Vanassche T, Belmans A, Vanhove J, Meyns J, Nadjmi N, Van Hemelen G, Winderickx P, Jacobs R, Politis C, Verhamme P. Tranexamic acid and bleeding in patients treated with non-vitamin K oral anticoagulants undergoing dental extraction: The EXTRACT-NOAC randomized clinical trial. PLoS Med. 2021 May 3;18(5):e1003601. doi: 10.1371/journal.pmed.1003601. eCollection 2021 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tranexamic Acid	Small molecule	10 %	Oral

Indications

No indication recorded.