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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03413891
Other study ID # S60131
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date February 7, 2018
Est. completion date March 19, 2020

Study information

Verified date August 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 222
Est. completion date March 19, 2020
Est. primary completion date March 19, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic Acid
Mouthwash
Other:
Placebo
Mouthwash

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven

Sponsors (2)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety outcome: any non-oral bleeding Any non-oral bleeding 7 days
Other Safety outcome: thrombotic event All thrombotic events including myocardial infarction, stroke, systemic embolism and venous thrombo-embolism 7 days
Primary Oral bleeding Any oral bleeding (early or delayed; minor, clinically relevant or major) 7 days: from randomization till end of follow-up
Secondary Procedural bleeding score Bleeding score assigned by operator (VAS 0-10) Day of extraction
Secondary Early bleeding Any oral bleeding occurring after the extraction up to and including day 1 after the extraction 1 day
Secondary Delayed bleeding Any oral bleeding occurring between day 2 and day 7 6 days
Secondary Minor bleeding Any oral bleeding not requiring unplanned medical contact 7 days
Secondary Clinically-relevant bleeding Any oral bleeding requiring unplanned medical contact 7 days
Secondary Major bleeding Any oral bleeding requiring blood transfusion, hospitalization or resulting in death 7 days
Secondary The number of reinterventions Any procedure in the oral cavity for the treatment of bleeding, performed by any dentist or maxillofacial surgeon 7 days
Secondary The number of unplanned interruptions of direct oral anticoagulant therapy The number of unplanned interruptions of direct oral anticoagulant therapy 7 days
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