Drugs to stop bleeding after tooth extraction

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Sponsor:

Collaborator:

Information provided by (Responsible Party):

Peter Verhamme, Universitaire Ziekenhuizen KU Leuven

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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :

1. Oral bleeding [ Time Frame: 7 days: from randomization till end of follow-up ]

   Any oral bleeding (early or delayed; minor, clinically relevant or major)

   
   

Secondary Outcome Measures :

1. Procedural bleeding score [ Time Frame: Day of extraction ]

   Bleeding score assigned by operator (VAS 0-10)

   
   
2. Early bleeding [ Time Frame: 1 day ]

   Any oral bleeding occurring after the extraction up to and including day 1 after the extraction

   
   
3. Delayed bleeding [ Time Frame: 6 days ]

   Any oral bleeding occurring between day 2 and day 7

   
   
4. Minor bleeding [ Time Frame: 7 days ]

   Any oral bleeding not requiring unplanned medical contact

   
   
5. Clinically-relevant bleeding [ Time Frame: 7 days ]

   Any oral bleeding requiring unplanned medical contact

   
   
6. Major bleeding [ Time Frame: 7 days ]

   Any oral bleeding requiring blood transfusion, hospitalization or resulting in death

   
   
7. The number of reinterventions [ Time Frame: 7 days ]

   Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon

   
   
8. The number of unplanned interruptions of direct oral anticoagulant therapy [ Time Frame: 7 days ]

   The number of unplanned interruptions of direct oral anticoagulant therapy

   
   

Other Outcome Measures:

1. Safety outcome: any non-oral bleeding [ Time Frame: 7 days ]

   Any non-oral bleeding

   
   
2. Safety outcome: thrombotic event [ Time Frame: 7 days ]

   All thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism

   
   

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413891

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Universitaire Ziekenhuizen KU Leuven

Research Foundation Flanders

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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.

Keywords provided by Peter Verhamme, Universitaire Ziekenhuizen KU Leuven:

Additional relevant MeSH terms:

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How do dentists stop bleeding after tooth extraction?

How long is too long for bleeding after tooth extraction?